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.
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 . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Sr. Manager serves as Regulatory Lead for development-stage and mature pharmaceutical products. He /She will manage, review, plan and prepare complex regulatory submission documents for global regulatory filings. Also, the Sr. manager will interpret regulations, and provide regulatory guidance to global regulatory teams. Has authority to submit complex submissions, act as primary AbbVie contact with US FDA, and lead US FDA meetings. Ensures technical accuracy and regulatory compliance of submissions. May train and provide guidance to lower level staff. As a Regulatory Lead or supportive role, the Sr. Manager will drive global regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives. Additionally, He/She will provide regulatory affairs perspective to project teams and other functions. Will support management with development and implementation of departmental strategies and policies. Primary product responsibility is in the Neuroscience Therapeutic Areas. May have responsibility to work in one or more therapeutic areas, covering multiple projects as needed. YOU ARE more than just a title, YOU ARE... A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Be responsible for providing regulatory input into project teams, Global Regulatory Plans, and Global Regulatory Teams. Be responsible for ensuring planned drug development activities comply with health authority guidelines and in cases where they do not, provides a critical analysis of associated risks and issues. Make recommendations to Regulatory Management and drug development teams in order to shape the global strategy in line with commercial objectives. Ensure Alignment with cross functional teams. Establish relationships with US colleagues as well as global regulatory team thereby ensuring local RA activities are in line with global and regional business priorities. Support the drug development strategy; defining options for Scientific Advice, creating briefing packages, and coordinating and leading US health authority meetings. Be responsible for US specific submissions (strategy and package preparation). Manage the preparation of clinical trial-supporting submissions. Define global submission strategies, identifying risks and issues. Be responsible for the communication of regulatory strategy in support of new product registration, in line with commercial objectives. Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during development, lifecycle management and/or maintenance. Ensure input from Advertising and promotional compliance team, as appropriate. Develop an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of AbbVie. Act as the primary contact with Regulatory Agencies. Plan and implement regulatory activities in support of lifecycle management (e.g Annual reports, label and CMC changes). Submit product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes to relevant functions. Ensure effective implementation of filing plans and publishing of documents for own projects and, if applicable, direct reports. Ensure effective planning, oversight and management of submissions including VDoc preparation and RAPID entries of assigned projects and for those of, if applicable, direct reports. Ensure archiving of activities, especially submissions, internal memos and key correspondence. Provide routine status updates to management. Be responsible for the Notification of Regulatory activities and related database entry/data accuracy. Be responsible for accurate and timely communication of submission and approvals to relevant cross functional teams for own projects and, if applicable, direct reports Provide project teams with clear constructive regulatory advice and intelligence to maximize business opportunities. Define regulatory requirements, develops and subsequently implements, plans in support of global/regional/country business initiatives. Provide input into development of processes to leverage global processes and infrastructure and maximize efficiency and effectiveness. Provide input into critical metrics and management reports. Maintains a performance and improvement culture. Ensure roles and responsibilities for external services within a project are clearly defined and documented. Proactively resolve issues related to outsourced activities. Follow all approved AbbVie procedures and guidance. Update and maintain appropriate standard operating procedures for the department. Prepare and deliver presentations as required Qualifications You Bring BS degree in a scientific field, plus six to eight years' experience in regulatory affairs; OR MS degree in a scientific field, plus four to six years' experience in regulatory affairs; OR PhD degree in a scientific field, plus two to four years' experience in regulatory affairs. In this role, we're looking for a leader who will : Act as an Owner Be Excellence Focused Act as an Influencer Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) 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.
01/25/2021
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 . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Sr. Manager serves as Regulatory Lead for development-stage and mature pharmaceutical products. He /She will manage, review, plan and prepare complex regulatory submission documents for global regulatory filings. Also, the Sr. manager will interpret regulations, and provide regulatory guidance to global regulatory teams. Has authority to submit complex submissions, act as primary AbbVie contact with US FDA, and lead US FDA meetings. Ensures technical accuracy and regulatory compliance of submissions. May train and provide guidance to lower level staff. As a Regulatory Lead or supportive role, the Sr. Manager will drive global regulatory strategy, advising on CMC, non-clinical and clinical development programs for assigned projects in line with business goals and objectives. Additionally, He/She will provide regulatory affairs perspective to project teams and other functions. Will support management with development and implementation of departmental strategies and policies. Primary product responsibility is in the Neuroscience Therapeutic Areas. May have responsibility to work in one or more therapeutic areas, covering multiple projects as needed. YOU ARE more than just a title, YOU ARE... A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Be responsible for providing regulatory input into project teams, Global Regulatory Plans, and Global Regulatory Teams. Be responsible for ensuring planned drug development activities comply with health authority guidelines and in cases where they do not, provides a critical analysis of associated risks and issues. Make recommendations to Regulatory Management and drug development teams in order to shape the global strategy in line with commercial objectives. Ensure Alignment with cross functional teams. Establish relationships with US colleagues as well as global regulatory team thereby ensuring local RA activities are in line with global and regional business priorities. Support the drug development strategy; defining options for Scientific Advice, creating briefing packages, and coordinating and leading US health authority meetings. Be responsible for US specific submissions (strategy and package preparation). Manage the preparation of clinical trial-supporting submissions. Define global submission strategies, identifying risks and issues. Be responsible for the communication of regulatory strategy in support of new product registration, in line with commercial objectives. Ensure that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during development, lifecycle management and/or maintenance. Ensure input from Advertising and promotional compliance team, as appropriate. Develop an awareness of key individuals within the Regulatory Agencies, to ensure a clear understanding of requirements and effective representation of AbbVie. Act as the primary contact with Regulatory Agencies. Plan and implement regulatory activities in support of lifecycle management (e.g Annual reports, label and CMC changes). Submit product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes to relevant functions. Ensure effective implementation of filing plans and publishing of documents for own projects and, if applicable, direct reports. Ensure effective planning, oversight and management of submissions including VDoc preparation and RAPID entries of assigned projects and for those of, if applicable, direct reports. Ensure archiving of activities, especially submissions, internal memos and key correspondence. Provide routine status updates to management. Be responsible for the Notification of Regulatory activities and related database entry/data accuracy. Be responsible for accurate and timely communication of submission and approvals to relevant cross functional teams for own projects and, if applicable, direct reports Provide project teams with clear constructive regulatory advice and intelligence to maximize business opportunities. Define regulatory requirements, develops and subsequently implements, plans in support of global/regional/country business initiatives. Provide input into development of processes to leverage global processes and infrastructure and maximize efficiency and effectiveness. Provide input into critical metrics and management reports. Maintains a performance and improvement culture. Ensure roles and responsibilities for external services within a project are clearly defined and documented. Proactively resolve issues related to outsourced activities. Follow all approved AbbVie procedures and guidance. Update and maintain appropriate standard operating procedures for the department. Prepare and deliver presentations as required Qualifications You Bring BS degree in a scientific field, plus six to eight years' experience in regulatory affairs; OR MS degree in a scientific field, plus four to six years' experience in regulatory affairs; OR PhD degree in a scientific field, plus two to four years' experience in regulatory affairs. In this role, we're looking for a leader who will : Act as an Owner Be Excellence Focused Act as an Influencer Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) 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.
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
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The Senior Manager, Regulatory Affairs will support regulatory activities for the Vaccine Business Unit as the regulatory representative on assigned Product Team(s). He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities (with strong emphasis on clinical/nonclinical). The Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies. He/she will have supervisory responsibilities. Essential Functions Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders, including funding agencies Develop innovative regulatory strategies that incorporates risk identification and mitigation Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions Oversee development of submission content, documents and timelines Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management Lead meetings both in-person and teleconferences with regulatory agencies for specific projects Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies Ensure regulatory product compliance for assigned products (e.g. agency commitments) As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams. Conduct and analyze regulatory research to understand competitor activity Interact with company partners and consultants for various regulatory matters as needed As required, develop procedures to support the regulatory affairs department May provide input to business unit strategies from regulatory perspective Will be responsible for a functional area and/or have direct reports The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills • Bachelor's degree in a life sciences or related discipline required. Approximately 10+ years of relevant pharmaceutical industry experience, with minimum 8 years in Regulatory Affairs. Less experience acceptable for suitable candidates with relevant industry experience and skill sets. • Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies • Ability to work on problems of diverse scope • Identifies priorities and key issues in complex situations and solves with minimal assistance • Exercises judgement within generally defined regulatory practices and policies • Experienced in leading cross-functional interactions (CMC, Clinical and Nonclinical) related to regulatory matters • Ability to guide, train, supervise and mentor personnel within the regulatory affairs team • Effective in both written and oral communication • Is able to direct work as required and manage complexity • Ability to anticipate and prevent potential issues • Understanding of regulatory issues and their touch points There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }
01/17/2021
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The Senior Manager, Regulatory Affairs will support regulatory activities for the Vaccine Business Unit as the regulatory representative on assigned Product Team(s). He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities (with strong emphasis on clinical/nonclinical). The Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies. He/she will have supervisory responsibilities. Essential Functions Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders, including funding agencies Develop innovative regulatory strategies that incorporates risk identification and mitigation Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions Oversee development of submission content, documents and timelines Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management Lead meetings both in-person and teleconferences with regulatory agencies for specific projects Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies Ensure regulatory product compliance for assigned products (e.g. agency commitments) As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams. Conduct and analyze regulatory research to understand competitor activity Interact with company partners and consultants for various regulatory matters as needed As required, develop procedures to support the regulatory affairs department May provide input to business unit strategies from regulatory perspective Will be responsible for a functional area and/or have direct reports The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills • Bachelor's degree in a life sciences or related discipline required. Approximately 10+ years of relevant pharmaceutical industry experience, with minimum 8 years in Regulatory Affairs. Less experience acceptable for suitable candidates with relevant industry experience and skill sets. • Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies • Ability to work on problems of diverse scope • Identifies priorities and key issues in complex situations and solves with minimal assistance • Exercises judgement within generally defined regulatory practices and policies • Experienced in leading cross-functional interactions (CMC, Clinical and Nonclinical) related to regulatory matters • Ability to guide, train, supervise and mentor personnel within the regulatory affairs team • Effective in both written and oral communication • Is able to direct work as required and manage complexity • Ability to anticipate and prevent potential issues • Understanding of regulatory issues and their touch points There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }