With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
09/12/2021
Full time
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).
03/01/2021
Full time
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/31/2021
Full time
DESCRIPTION The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU. MAJOR RESPONSIBILITIES AND DUTIES Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries; Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators; Liason with US FDA, EU and other regulatory authorities as assigned; Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU; Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development; Ensure compilation of electronic submissions according to current health authority standards; Provide regulatory oversight by developing and implementing SOP's; Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects Additional Skills & Qualifications: BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals NDA or BLA filing experience a plus Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines Good leadership, organization, problem-solving & communication skills Excellent written and oral communication skills Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus Knowledge of EU regulatory regulations a plus Ability to manage priorities and workflow, managing multiple projects and meeting deadlines Acute attention to detail Good judgement with the ability to make timely and sound decisions Skills: Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical Top Skills Details: regulatory affairs, regulatory Strategy, FDA submission experience Experience Level: Expert Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
01/30/2021
Full time
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
Job Summary: Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products. Essential Duties & Responsibilities Responsible for preparation of eCTD documentation for variety of regulatory submissions, most importantly NDA and IND submissions to CDER, CBER or CDRH. Manages advisement of project teams on routine regulatory matters. Ensures compliance to the requirements from U.S. and foreign regulatory agencies. Participates in project team discussions and related activities regarding preclinical and clinical aspects of drug development, and coordinates with CMC regulatory personnel on related items. Represents RA interests in company subteams for planning and strategy discussions. Coordinates regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility. Accepts other specific research, due diligence or other matters as assigned. Non-Essential Duties & Responsibilities: Informs and educates other Supernus colleagues about Regulatory issues as needed. Supervisory Responsibilities: Supervision of Regulatory personnel as assigned. Knowledge & Other Qualifications: B.S. Degree in life science or related field, advanced degree strongly preferred. Minimum of 8 years of direct experience in a pharmaceutical, medical device and/or biotech environment, 10 to 12 years' experience preferred. Experience with regulations/guidelines governing development of pharmaceuticals, biologics and medical devices. Comprehensive knowledge of applicable regulatory law and guidance and experience in application of this knowledge to protect team settings. Prior experience with management of direct reports. Detail oriented with good analytical skills. Strong organizational skills with attention to detail and accuracy. Excellent verbal and written communication skills in English language. Ability to work well under pressure. Ability to handle multiple competing priorities. Regulatory Affairs Certification is desirable but not required. Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Experience in compilation of Regulatory submissions using eCTD (electronic common technical documents) preferred. Physical Requirements / Work Environment: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Other Characteristics: Ability to work independently and as part of a team. Ability to maintain high ethical standards of integrity and quality. Capable of being innovative and dynamic in approach to work. Capable of performing other duties as assigned by management. Authorized to legally work in the United States without visa sponsorship. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. #CB
01/30/2021
Full time
Job Summary: Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products. Essential Duties & Responsibilities Responsible for preparation of eCTD documentation for variety of regulatory submissions, most importantly NDA and IND submissions to CDER, CBER or CDRH. Manages advisement of project teams on routine regulatory matters. Ensures compliance to the requirements from U.S. and foreign regulatory agencies. Participates in project team discussions and related activities regarding preclinical and clinical aspects of drug development, and coordinates with CMC regulatory personnel on related items. Represents RA interests in company subteams for planning and strategy discussions. Coordinates regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility. Accepts other specific research, due diligence or other matters as assigned. Non-Essential Duties & Responsibilities: Informs and educates other Supernus colleagues about Regulatory issues as needed. Supervisory Responsibilities: Supervision of Regulatory personnel as assigned. Knowledge & Other Qualifications: B.S. Degree in life science or related field, advanced degree strongly preferred. Minimum of 8 years of direct experience in a pharmaceutical, medical device and/or biotech environment, 10 to 12 years' experience preferred. Experience with regulations/guidelines governing development of pharmaceuticals, biologics and medical devices. Comprehensive knowledge of applicable regulatory law and guidance and experience in application of this knowledge to protect team settings. Prior experience with management of direct reports. Detail oriented with good analytical skills. Strong organizational skills with attention to detail and accuracy. Excellent verbal and written communication skills in English language. Ability to work well under pressure. Ability to handle multiple competing priorities. Regulatory Affairs Certification is desirable but not required. Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF. Experience in compilation of Regulatory submissions using eCTD (electronic common technical documents) preferred. Physical Requirements / Work Environment: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Other Characteristics: Ability to work independently and as part of a team. Ability to maintain high ethical standards of integrity and quality. Capable of being innovative and dynamic in approach to work. Capable of performing other duties as assigned by management. Authorized to legally work in the United States without visa sponsorship. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. #CB
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Director, Regulatory Affairs also ensures that there is labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans and formulates regulatory labeling strategies for implementation of new and revised prescribing information. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure a integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
01/28/2021
Full time
Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Director, Regulatory Affairs also ensures that there is labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans and formulates regulatory labeling strategies for implementation of new and revised prescribing information. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Advises and oversees internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure a integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI
The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization. The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes. The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV) Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products Support development of phase-appropriate method validation approaches for release and characterization testing Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products Set strategic objectives, provide clear direction, and manage execution for the AS&T function Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc. Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and stability programs for cell and gene therapy products to support clinical development and commercial registration Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience 7+ years of analytical management experience to support development of biological products Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA) Expertise in leading activities to support technical investigations, deviations and change controls Demonstrated experience managing analytical testing at external contract organizations Preferred: Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment Strong critical thinking and problem-solving skills Excellent written and verbal communication skills Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses Travel Requirements This position requires some travel (10%) Location This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed. Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
01/23/2021
Full time
The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization. The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes. The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV) Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products Support development of phase-appropriate method validation approaches for release and characterization testing Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products Set strategic objectives, provide clear direction, and manage execution for the AS&T function Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc. Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and stability programs for cell and gene therapy products to support clinical development and commercial registration Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience 7+ years of analytical management experience to support development of biological products Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA) Expertise in leading activities to support technical investigations, deviations and change controls Demonstrated experience managing analytical testing at external contract organizations Preferred: Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment Strong critical thinking and problem-solving skills Excellent written and verbal communication skills Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses Travel Requirements This position requires some travel (10%) Location This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed. Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Description The Director, Clinical Regulatory Affairs is responsible for assisting the VP of Regulatory Affairs with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. The position is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities. This position would be held accountable for establishing strategic plans, policies, and procedures to ensure Avidity fulfills its obligations and commitment. Responsibilities include: Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members representing the regulatory department in the development process Communicate requirements and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets Communication of regulatory strategies and plans to ensure alignment with the overall project plan and business strategy Direct and lead regulatory execution strategies and regulatory submissions Contribute to compliance related functions such as GxP projects, governance initiation, draft and review SOP's, review of contracts, and quality/supply agreements Oversight and management of external regulatory vendors and regulatory resources Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings Assist in the management and oversight of regulatory activities relating to clinical trials Assist with leadership of the regulatory team and provide guidance to the wider organization Advise on labeling, promotional review and other post marketing/commercial regulatory activities Assure compliance with regulatory reporting requirements Represent the Company's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business Perform other duties as required Desired Knowledge and Abilities: Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activities Excellent knowledge of regulatory, GxP, compliance, laws, and regulations for pharmaceutical products Experience developing products, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc. Proven ability to establish strategy and to translate it into an effective, long term action plan Demonstrated success in effectively leading regulatory teams Thorough understanding of the regulatory process from development through commercialization Strong project management skills Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development, Regulatory and Quality Control Established track record with evidence of excellent project management, problem solving, collaborative, leadership, and communication skills Strong written and oral communication skills Able to grasp complex technical issues and make sound decisions based on data and information from various sources Ability to foster and promote internal collaboration Education and Experience: Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus Minimum of 8-10 years of experience in pharmaceutical / biotech Minimum 4-6 years in a management role within Regulatory Avidity offers very competitive benefits and is an Equal Opportunity Employer.
01/22/2021
Full time
Description The Director, Clinical Regulatory Affairs is responsible for assisting the VP of Regulatory Affairs with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. The position is also responsible for oversight and execution of global regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, Designations, etc.) and regulatory compliance, including interfacing with internal and external consultants and with International Regulatory Authorities. This position would be held accountable for establishing strategic plans, policies, and procedures to ensure Avidity fulfills its obligations and commitment. Responsibilities include: Establish regulatory strategies and process by collaborating and coordinating with relevant development and CMC team members representing the regulatory department in the development process Communicate requirements and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets Communication of regulatory strategies and plans to ensure alignment with the overall project plan and business strategy Direct and lead regulatory execution strategies and regulatory submissions Contribute to compliance related functions such as GxP projects, governance initiation, draft and review SOP's, review of contracts, and quality/supply agreements Oversight and management of external regulatory vendors and regulatory resources Lead the coordination of regulatory meeting packages and attend Regulatory Authority meetings Assist in the management and oversight of regulatory activities relating to clinical trials Assist with leadership of the regulatory team and provide guidance to the wider organization Advise on labeling, promotional review and other post marketing/commercial regulatory activities Assure compliance with regulatory reporting requirements Represent the Company's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business Perform other duties as required Desired Knowledge and Abilities: Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies, assessment of corporate risks related to regulatory and development activities Excellent knowledge of regulatory, GxP, compliance, laws, and regulations for pharmaceutical products Experience developing products, including INDs, CTAs, NDAs, MAAs, expedited approval pathways, etc. Proven ability to establish strategy and to translate it into an effective, long term action plan Demonstrated success in effectively leading regulatory teams Thorough understanding of the regulatory process from development through commercialization Strong project management skills Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development, Regulatory and Quality Control Established track record with evidence of excellent project management, problem solving, collaborative, leadership, and communication skills Strong written and oral communication skills Able to grasp complex technical issues and make sound decisions based on data and information from various sources Ability to foster and promote internal collaboration Education and Experience: Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus Minimum of 8-10 years of experience in pharmaceutical / biotech Minimum 4-6 years in a management role within Regulatory Avidity offers very competitive benefits and is an Equal Opportunity Employer.
Global Blood Therapeutics
San Francisco, California
SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
01/21/2021
Full time
SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Company Description: Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at . Position Overview: Molecular Templates is seeking a highly experienced and dynamic professional to oversee and direct chemistry, manufacturing and controls (CMC) development and manufacturing strategies for new and mature products. This Sr. Manager will provide guidance and support to internal groups such as process and product development, quality, manufacturing, supply chain and regulatory affairs, as well as to outside groups, such as contract manufacturing organizations and contract laboratories to ensure that products are manufactured in compliance with all applicable regulations and protocols. Additionally, this role will be responsible for providing strategic input and risk assessments and oversee preparation of CMC regulatory submissions. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, contractors and external regulatory agencies. Job Responsibilities will include: Participate in identifying, creating, and sustaining CMC processes to successfully support the growing pipeline of product candidates Oversee Operations functions within CMC, including but not limited to defining specifications, trending and analyzing batch data, maintain internal and external CMC documents, and supporting and defining aspects of distribution and release management Work within CMC and process development functions to help generate manufacturing summary reports to inform product, process, and analytical development and help identify and monitor product yields and/or product quality Compile, review and approve high-quality CMC modules for development and marketing registration applications, annual reports, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and FDA/Health Authority questions Manage efforts at contract service providers to support drug substance and drug product manufacturing, and development efforts as needed Manage and ensure compliance with all reporting requirements, including annual and periodic reports Assess and communicate CMC requirements to ensure all development activities are compliant with applicable regulations and guidelines Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones Serve as a CMC project contact with external and internal clients, as needed Support the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions, and present findings to management Identify project issues and contribute to the development of alternative CMC development strategies Qualifications: Advanced degree in the Life Sciences or related field, required Minimum of six (6) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operation efforts Experience in process or analytical development, qualification and validation strategies, preferred Excellent written and verbal communication skills Excellent computer skills Excellent analytical skills and problem-solving skills Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment Ability to work collaboratively with cross-functional teams and contractors to drive results and meet company objectives Ability to function independently and exercise good judgement, as well as in a team-based environment Minimal travel required Reporting Structure: This position currently has no supervisory responsibilities. This position reports to Director, CMC. Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits. Molecular Templates Inc
01/19/2021
Full time
Company Description: Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at . Position Overview: Molecular Templates is seeking a highly experienced and dynamic professional to oversee and direct chemistry, manufacturing and controls (CMC) development and manufacturing strategies for new and mature products. This Sr. Manager will provide guidance and support to internal groups such as process and product development, quality, manufacturing, supply chain and regulatory affairs, as well as to outside groups, such as contract manufacturing organizations and contract laboratories to ensure that products are manufactured in compliance with all applicable regulations and protocols. Additionally, this role will be responsible for providing strategic input and risk assessments and oversee preparation of CMC regulatory submissions. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, contractors and external regulatory agencies. Job Responsibilities will include: Participate in identifying, creating, and sustaining CMC processes to successfully support the growing pipeline of product candidates Oversee Operations functions within CMC, including but not limited to defining specifications, trending and analyzing batch data, maintain internal and external CMC documents, and supporting and defining aspects of distribution and release management Work within CMC and process development functions to help generate manufacturing summary reports to inform product, process, and analytical development and help identify and monitor product yields and/or product quality Compile, review and approve high-quality CMC modules for development and marketing registration applications, annual reports, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and FDA/Health Authority questions Manage efforts at contract service providers to support drug substance and drug product manufacturing, and development efforts as needed Manage and ensure compliance with all reporting requirements, including annual and periodic reports Assess and communicate CMC requirements to ensure all development activities are compliant with applicable regulations and guidelines Develop and distribute periodic reports on performance, issues, risks, and schedules of key activities, events, or milestones Serve as a CMC project contact with external and internal clients, as needed Support the review of CMC content for accuracy, including data verification, clarity, consistency, and conformance to writing conventions, and present findings to management Identify project issues and contribute to the development of alternative CMC development strategies Qualifications: Advanced degree in the Life Sciences or related field, required Minimum of six (6) years of relevant experience in pharmaceutical, biotechnology or a related industry focused on drug development Demonstrated experience with large molecule biologics and minimum two (2) years directly involved with CMC operation efforts Experience in process or analytical development, qualification and validation strategies, preferred Excellent written and verbal communication skills Excellent computer skills Excellent analytical skills and problem-solving skills Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment Ability to work collaboratively with cross-functional teams and contractors to drive results and meet company objectives Ability to function independently and exercise good judgement, as well as in a team-based environment Minimal travel required Reporting Structure: This position currently has no supervisory responsibilities. This position reports to Director, CMC. Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits. Molecular Templates Inc
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director of Regulatory Affairs - Device/Combination products supports regulatory objectives for the company's development and marketed device/combination products including coordination, management of global submissions and CE technical files/design dossiers. Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings. Supports the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation - MDR and IVDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all Allergan policies and procedures. Key Duties / Responsibilities: Leads and/or supports device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product. Supports regulatory submissions, regulatory operations, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable, per product type. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs. Provides regulatory policy, intelligence interpretation and strategy (e.g. Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures. Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivates meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety, International Regulatory Affairs and external third party regulatory experts. Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability Supports and develops global regulatory teams to meet company objectives. In addition, the incumbent is the key regulatory contact for International Regulatory Affairs. Qualifications Bachelor's degree in scientific discipline is required. A Master's degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. 12 years of regulatory experience in the medical device/combination products industry; OR a Master's degree, or JD with a minimum of 8years of Regulatory experience in the medical device and combination products industry. Experience in the CE Marking process, global regulatory strategy and regulatory submission process. Sound technical skills including working knowledge of medical device and combination products. Experience with eCTD tools and EDMS applications. Proven experience in and ability to manage relationships with regulatory agency personnel at all levels. Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance for Device/Combination Products. Strong knowledge of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. Ability to travel up to [15] % of time Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/16/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director of Regulatory Affairs - Device/Combination products supports regulatory objectives for the company's development and marketed device/combination products including coordination, management of global submissions and CE technical files/design dossiers. Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings. Supports the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation - MDR and IVDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all Allergan policies and procedures. Key Duties / Responsibilities: Leads and/or supports device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product. Supports regulatory submissions, regulatory operations, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable, per product type. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs. Provides regulatory policy, intelligence interpretation and strategy (e.g. Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures. Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivates meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety, International Regulatory Affairs and external third party regulatory experts. Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability Supports and develops global regulatory teams to meet company objectives. In addition, the incumbent is the key regulatory contact for International Regulatory Affairs. Qualifications Bachelor's degree in scientific discipline is required. A Master's degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. 12 years of regulatory experience in the medical device/combination products industry; OR a Master's degree, or JD with a minimum of 8years of Regulatory experience in the medical device and combination products industry. Experience in the CE Marking process, global regulatory strategy and regulatory submission process. Sound technical skills including working knowledge of medical device and combination products. Experience with eCTD tools and EDMS applications. Proven experience in and ability to manage relationships with regulatory agency personnel at all levels. Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance for Device/Combination Products. Strong knowledge of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. Ability to travel up to [15] % of time Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease. The Regulatory Specialist will report to the Director, Regulatory Affairs and support regulatory activities critical to the company's product development objectives. These may include preparing regulatory documents, serving as the regulatory representative on assigned clinical trials, providing input into the development of processes and timelines in support of designated regulatory activities, and tracking submissions. Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and lots of fun. Responsibilities include (but are not limited to) the following : Serve as regulatory representative for designated clinical trials Maintain IND and prepare documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates) Assist with preparing clinical trial applications (CTA) and investigational new drug applications (IND) Post and maintain record of studies on ClinicalTrials.gov Perform in depth review of study documents and track status of submissions Review investigator packages and authorize drug shipments to clinical sites Assist with internal review of regulatory deliverables and development of submission timelines Use tools to track and manage regulatory commitments, submissions, and correspondence Ensure quality, consistency, completeness and accuracy for all regulatory submissions Assist Regulatory department in the update, enhancement, and creation of internal policies, working practices and procedures. Requirements : Minimum of a bachelor's degree, in the life sciences preferred. Minimum of 4 years regulatory experience, international experience desirable. Experience working with CROs on regulatory submissions in support of clinical trials Knowledge of current Global (FDA, EMA) regulations and guidance of requirements for investigational products, IND and CTA submission requirements Experience with cloud-based document management programs (e.g., Arivis) and/or document management systems is preferred CMC experience desirable but not required Experience with EU CTA submissions is desirable Ability to work well and foster collaboration within cross-functional teams Strong verbal/written English communication skills Attention to detail; ability to manage multiple projects as well as organize and prioritize activities Organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously Apply today. We'd love to meet you!
01/15/2021
Full time
Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease. The Regulatory Specialist will report to the Director, Regulatory Affairs and support regulatory activities critical to the company's product development objectives. These may include preparing regulatory documents, serving as the regulatory representative on assigned clinical trials, providing input into the development of processes and timelines in support of designated regulatory activities, and tracking submissions. Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and lots of fun. Responsibilities include (but are not limited to) the following : Serve as regulatory representative for designated clinical trials Maintain IND and prepare documents for IND submissions (cover letters, forms, IND annual reports, IB annual updates) Assist with preparing clinical trial applications (CTA) and investigational new drug applications (IND) Post and maintain record of studies on ClinicalTrials.gov Perform in depth review of study documents and track status of submissions Review investigator packages and authorize drug shipments to clinical sites Assist with internal review of regulatory deliverables and development of submission timelines Use tools to track and manage regulatory commitments, submissions, and correspondence Ensure quality, consistency, completeness and accuracy for all regulatory submissions Assist Regulatory department in the update, enhancement, and creation of internal policies, working practices and procedures. Requirements : Minimum of a bachelor's degree, in the life sciences preferred. Minimum of 4 years regulatory experience, international experience desirable. Experience working with CROs on regulatory submissions in support of clinical trials Knowledge of current Global (FDA, EMA) regulations and guidance of requirements for investigational products, IND and CTA submission requirements Experience with cloud-based document management programs (e.g., Arivis) and/or document management systems is preferred CMC experience desirable but not required Experience with EU CTA submissions is desirable Ability to work well and foster collaboration within cross-functional teams Strong verbal/written English communication skills Attention to detail; ability to manage multiple projects as well as organize and prioritize activities Organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously Apply today. We'd love to meet you!