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Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SUMMARY Develop the strategic direction for Global Research QA including activities under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture of solution oriented and evidence-based mind-set with openness for innovative ways of working with new technologies/ Implementing strategic and tactical plans to drive sustainable improvements. Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/ vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP activities being executed at DS cross-functional teams (i.e , Research, Translational Oncology, GDO etc.,). Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions. Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place. Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. Responsibilities Leads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices. Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight. Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies. Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc. Ensures that laboratories and / or vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated. Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders. Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings. Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight. Develop and implement the Research Quality QRB with key partners and collaborators. Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and regulators. Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDA Ensure GLP regulated activities for computer systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being adhered to. Ensure that Clinical Development activities (i.e , protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance. Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation. Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co-lead quality council as necessary. Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization. Allocates and manages financial and human resources within the function. Accountable for performance, progress and success of the team by ensuring that objectives are clear, in place and that teams are managed to drive results. QUALIFICATIONS Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines PhD or other post graduate degree strongly preferred Experience Qualifications Must have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions; broad understanding of global expectations of Health Authorities in the GxP area; profound understanding of the science of product development. Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines. Must have proven expertise within Quality Assurance Research to support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required Must have proven people management experience including experience in a matrix, global environment required Must have strong communications skills, written and oral. Travel Must have the ability to travel up to 20%. Domestic and International travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This position serves as the primary contact for interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position also interacts with other therapeutic area leaders and joint Alliance partners. Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes, and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy, corporate goals, and regional regulatory requirements/precedence. Represent Daiichi Sankyo's regulatory group in internal and external development project meetings. Provide guidance to peers and cross-functional team members regarding strategic regulatory issues. Develop timeline and strategic input with feedback from the regional strategists in terms of Health Authority meetings globally. Provide leadership and set direction, acting as a key decision-maker and/or arbitrator on global projects. Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret regulatory guidelines, regulatory precedence and competitive landscape with respect to impact on development programs. Ability to serve and participate on internal and external panels related to Health Authority initiatives. Review of clinical study protocols, health authority dossiers and briefing books. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree required Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred Experience Qualifications 10 or More Years Experience in the pharmaceutical industry 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology Managerial experience Experience with ex-US regulatory authorities Travel - Ability to travel up to 20% In-house office position that may require occasional travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine. Responsibilities Developing and leading global regulatory strategies to support business objectives Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records Work closely with business leadership to ensure regulatory strategy aligns with commercial goals Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently What your background might look like Experience with complex medical devices, such as some combination of: Software and artificial intelligence based devices Clinical decision support software Medical imaging Oncology Cardiology Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR Software validation and risk management Cybersecurity in medical devices Machine learning validation requirements Lifecycle management of medical devices/IVDs Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions Relevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience working in a startup-like environment Experience interacting with regulators Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs Excellent attention to detail Strong project management skills and the ability to execute on project plans in a fast-paced environment Scientific background Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred. Minimum of 7+ years of experience in Regulatory Affairs related to medical devices Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

Job Title: Associate Director - Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: Full time FLSA: Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit and engage with us on LinkedIn and Twitter . The Opportunity The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. The position is responsible for oversight and execution of global regulatory activities, for product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.) and regulatory compliance. The position is expected to capably interface with internal senior leadership and external consultants/vendors as well as with domestic and international Regulatory Authorities. The optimal candidate for the position will be passionate about developing novel therapeutics for people in need. What You Will Contribute Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members - represent the regulatory function as a core development team contributor Communicate creative ideas and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans and timelines Develop and communicate regulatory strategies and plans that align with project objectives and overall business strategy Direct and lead execution plans for regulatory submissions Proactively identify potential program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful outcomes Lead the coordination and authoring of regulatory meeting packages and contribute to/lead Regulatory Authority meetings Assist in the management and oversight of regulatory activities relating to clinical trials and other operational aspects of clinical trial preparation Determine and communicate documentation requirements for submissions in a transparent and timely way to enable efficient regulatory submissions Prepare/author documents in collaboration with CRO/regulatory vendors for submission of clinical trial applications in US, and ex-US countries Review submission components to ensure compliance with health authority expectations, including associated guidelines and regulations. Provide oversight and management of external regulatory vendors and regulatory resources Assist in the management, oversight, authoring and coordination of Request for Information (RFI's) received from Health authorities for clinical trials and IND's Assist with mentorship of the regulatory team and use experience and expertise to provide guidance to the wider organization Advise on labeling, promotional review and other post marketing/commercial regulatory activities Assure compliance with regulatory reporting requirements Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments. 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 What We Seek Bachelor's Degree required; Advanced Degree a plus Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus Minimum of 7 years of experience in pharmaceutical / biotech with a minimum of 4+ years in clinical Regulatory Affairs Comprehensive knowledge of current US and ex-US regulations and guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies and assessment of risks related to regulatory and development activities as well as experience in leading Regulatory Authority interactions/meetings. Experience in authoring briefing books and submission packages for Regulatory Authority meetings Experience developing products, including INDs, CTAs, NDAs/BLAs, 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 cross-functional teams Thorough understanding of the regulatory process from development through commercialization Strong project management skills Established track record with evidence of excellent problem-solving, collaboration, 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 What We Will Provide to You: The base salary range for this role is $170,000 - $187,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Senior Manager/Associate Director, Supply Chain Planning Boston, MA, USA Req Thursday, August 15, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Senior Manager/Associate Director, Supply Chain Planning to join our team. The Senior Manager/Associate Director, Supply Chain Planning will be responsible for supply chain planning for clinical supplies (clinical trial material) across a number of small molecule drug development programs in support of Xenon's clinical trials. The Senior Manager, Supply Chain Planning will additionally be responsible for developing and managing end-to-end supply chain plans for Xenon's products. The candidate will collaborate closely with the CMC and Supply Chain Management teams, as well as with key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs, and Quality Assurance. This position reports to the Senior Director, Supply Chain Systems and will be in Boston, MA, USA. This role is a hybrid position, requiring a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate's education and industry experience. RESPONSIBILITIES: Manage end-to-end Supply Chain Planning, including but not limited to: Demand, Supply, and Inventory Plans; Master Data, processes, and associated systems, and; Management of forecasting and CMO requirements in support of our Sales and Operations Planning (S&OP) processes. Manage Master Data, processes, and associated systems, including but not limited to: Managing the creation, implementation, and maintenance of master data management solutions that enable users to optimize system capabilities; Enrich master data elements and optimize the flow of data between users and stakeholders; Ensuring that data are accurate by conducting audits and identifying trends that may indicate problems with data quality, and; Designing and implementing data management policies and procedures to ensure organizational compliance with pertinent industry regulations. Lead and manage Supply Chain Planning projects that incorporate people, process and technology requirements as part of a cross-functional team. Prepare and present Key Performance Indicators (KPI) reports, perform root-cause analysis assessments, and implement continuous improvement actions, as needed. Produce regular performance reports based on KPI analysis. Collaborate with Management, the Supply Chain Management team and other internal teams, as needed. Lead the transformation of the Supply Chain Management department in-line with, or ahead of, the demands of our businesses. Develop the skills and capabilities of Supply Chain Management best practices, business sector knowledge and analytics across the team. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Other duties as assigned. Some international travel may be required. QUALIFICATIONS: A university degree in health sciences, life sciences or physical sciences (or equivalent) with 7+ years' experience in the pharmaceutical/biotechnology industry. A minimum of 5 years' management level experience in a pharma or biotech environment. Job level commensurate with years of experience. Experience and deep knowledge of pharmaceutical Supply Chain Planning and Master Data as they pertain to people, process and technology needs. Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, guidelines and directives. Experience with Master Data and ERP systems, as well as planning applications design, implementation, and user acceptance testing (UAT) is required. Proficiency with Microsoft applications, electronic data capture systems and inventory management systems. Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel. Excellent attention to detail and commitment to providing accurate, high-quality work. Good organizational skills and the ability to manage multiple competing priorities. Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team. The base salary range for this role is $143,500 to $200,000 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here . To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Oversees multiple programs, alliances, large trials, such as global clinical development program for multiple product candidates with one or more indications or a single large program with multiple Ph II/III studies: Reviews regulatory documents from cross functional, holistic perspective. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Responsibilities: Clinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL). Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects. Study Strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions. Study Planning and Execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level. Study Outputs: For large studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions. External Collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report's performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department's planning for staff and cross-functional staffing plans for the Therapeutic Area. Additional non-study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late-stage compounds; Committee member, in-licensing and acquisitions. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: MD with relevant clinical experience required Postgraduate training in TA or related specialty required Experience Qualifications 7 or More Years experience required 4 or More Years managing Clinical Development group required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Position Summary: MannKind Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs. Reporting to MannKind's Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. They will be a key member of the project leadership teams and will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This individual will direct and coordinate activities in regulatory and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around this critical functional area. S/he will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively, interacting closely with internal peers and externally with FDA, EMA, and other key stakeholders. This position has the responsibility for tracking trends and requirements in the global market and the impact that the changes will have on the company's portfolio. They will also be responsible for analyzing and evaluating the company's regulatory procedures to ensure the attainment of financial and strategic goals. This includes ensuring that all corporate regulatory goals are clearly defined, met, and are in compliance with all current industry standards globally. S/he must be adept at formulating and driving strategy, and also be tactically oriented, preparing and writing submissions and playing a hands-on role in regulatory submissions. Furthermore, this individual will have demonstrated an ability to partner effectively with multiple functions, including Clinical, Research, Development, Medical Affairs, and Quality. At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science. Strong interpersonal skills are necessary, as this individual will serve as a voice for the company internally as a trusted member of the team. A proven ability to communicate with other members of the executive management team, Board members, external thought leaders, and research and development staff in a fast-paced environment is crucial. Furthermore, the capacity for strategic thinking is highly important. In short, outstanding leadership and management skills with rigorous scientific intellect and standards and understanding of the business aspects of drug development are required. Finally, an ability to think and manage strategically, with an attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases. Principal Responsibilities: Collaborate with Clinical Team to develop and implement the US and global regulatory affairs plan across product portfolio. Oversee development and refinement of regulatory policies, procedures, and SOPs. Work closely with commercial, clinical development, and Medical Affairs in designing and implementing launch strategies and tactics, and life cycle planning. Provide regulatory assessments of product opportunities and threats. Provide regulatory expertise in the development and approval of promotional materials. Collaborate with Commercial, Legal, and Clinical for development and review of labeling, advertising, and promotional materials. Lead, develop, mentor, and manage the Regulatory Affairs team. Develop and advance the organization's policy and procedures for regulatory affairs and compliance to maintain a compliant culture. Anticipate global regulatory changes and develop proactive strategies accordingly. Provide strategic guidance to drug development on all aspects of regulatory requirements. Interpret FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders, developing and implementing successful issue resolution strategies. Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities. Communicate with regulatory agencies regarding submission strategies, potential regulatory pathways, or clarification and follow-up of submissions under review. Develop and plan innovative regulatory strategies for label enhancements and life cycle product management. Counsel and advise senior management / CMO on status of global regulatory affairs strategies and tactics, procedures and practices, and provides critical risk assessments of the strategic alternatives for regulatory filings. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Provide review and approval of all external-facing communications advertising and promotional labeling to ensure compliance with corporate policy, US and international laws and regulations. Assess project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time. Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements. Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidelines. Establish, maintain, direct, and communicate a global benefit-risk strategy for each pre-market, marketed, and future MannKind product that includes risk management and minimization. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Education and Experience Qualifications: Bachelor's degree in a scientific discipline; Graduate degree (Ph.D. or PharmD) strongly preferred. Progressive related experience in regulatory affairs in the pharmaceutical/biotech industry. Experience with designing and executing creative regulatory strategies for innovative products. Must have a solid understanding of FDA regulations and ICH guidelines, as well as comprehensive experience in the drug promotional and development processes. Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial. Experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics preferred. Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management. Excellent organizational, written and verbal communications, project, and time management skills needed to drive multiple ongoing projects simultaneously. Results-driven and team-oriented with the ability to influence outcomes. Ability to interpret, communicate, and present regulatory information in a clear, concise, and timely manner. Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients.

Company Overview: Based in San Diego, CA, our client is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Join our dynamic team and be part of the transformative journey! Position Overview: We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team. This pivotal role will spearhead regulatory strategies and activities concerning the development and approval of cell therapy products. Reporting directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives. Key Responsibilities: Lead strategic planning and execution of clinical regulatory strategies, agency interactions, and submissions. Collaborate with the Executive team to define regulatory strategies for both internal and partnership programs. Oversee the compilation, review, and submission of regulatory interactions with agencies, ensuring accuracy, completeness, and timeliness. Provide guidance on Regulatory CMC strategy and support development teams in interpreting and applying regulations and guidance documents. Offer strategic and regulatory compliance input to protocols, reports, and other source documents. Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project teams. Lead regulatory meetings with agencies and develop briefing packages for such engagements. Collaborate with cross-functional teams and support functions, including full-time staff and independent consultants, as required. Qualifications: Minimum of 10 years of experience in Clinical Regulatory Affairs within drug development. Advanced degree in a scientific discipline is mandatory. Extensive hands-on regulatory experience leading Clinical, Nonclinical, and CMC strategy and documentation. Proven track record of developing regulatory submissions in the biotechnology sector, preferably in cell therapy. Strong knowledge of FDA and EMA regulations. Experience with mechanisms to expedite agency interactions, such as Fast-Track and Breakthrough Designation. Excellent communication skills with the ability to influence stakeholders internally and externally. Self-motivated, with the ability to work independently or as part of a team. Strategic thinker with strong problem-solving skills. Exceptional organizational skills with the ability to prioritize tasks in a fast-paced environment. Physical Requirements: Ability to communicate verbally and in writing effectively. Regular use of office equipment such as computers and workstations. Occasional lifting or moving of up to 10 pounds may be required. Work Environment: Work primarily in an office environment with occasional work in or around laboratory settings. This position requires 100% on-site work at our corporate headquarters in San Diego, CA. Flexibility for evening and weekend work as necessary. This job description offers an opportunity for seasoned regulatory professionals to contribute significantly to groundbreaking advancements in cell therapy.

You will need to login before you can apply for a job. Director of State Affairs (Regional Midwest) About this role We are recruiting four regional Directors of State Affairs to lead BlackRock's advocacy at the state and local level in the United States. Each individual will be responsible for developing, prioritizing, tracking, and communicating BlackRock's public policy priorities at the state and local level for their region. This job posting is for the Director, State Affairs for the Regional Midwest. About the Government Affairs & Public Policy Group BlackRock has a long history of service as a trusted, expert resource to governments and policymakers around the world. Since the Government Affairs & Public Policy team was created in 2009, it has steadily grown, transformed, and established BlackRock as a respected advocate for investors and the millions of retirees we serve. In recent years, that work has extended to long-term challenges such as the retirement crisis, energy security, and investment in critical infrastructure. Key Responsibilities Lead state-level advocacy and engagement with policymakers and regulators. Build and maintain networks of contacts both within BlackRock and externally with state-level policy makers. Identify and monitor key U.S. public policy issues that impact investors at the state and local level; shape BlackRock's position on these issues. Provide technical recommendations legislative and regulatory proposals, collaborating closely with Legal & Compliance and other teams to ensure alignment of views across the firm. Take initiative to define and implement response strategies across states. Work closely with internal stakeholders to understand the interests of BlackRock and our clients as they relate to state-level government affairs developments; involve subject matter experts as appropriate; assist with the development and management of internal working groups. Provide expert level information on priority issues with key stakeholders across the firm. Represent BlackRock's views with trade associations, consultants, and clients. Prepare briefing and presentation materials for engagements with policymakers, regulators, and clients. Write comment letters to policy makers and contribute to thought leadership publications on relevant policy topics. Desired Qualifications Bachelor's degree required. Grassroots organization and campaign experience preferred. 7-10+ years of work experience in state lobbying; financial services expertise preferred. Exceptional communication skills. Must be able to present complex concepts in a concise and understandable way. Demonstrated excellence in written communication. Strong political acumen, thorough understanding of state-level public policy, and ability to be effective with members of both political parties. Ability to work in a fast-paced environment with multiple ongoing deliverables and tight deadlines. Proficiency in PowerPoint, Excel, and Word. Strong research and writing skills; strategic and creative thinking aptitude. Ability to clearly articulate ideas to senior internal and external audiences, including leaders within the firm, outside counsel, clients, and third-party organizations. Excellent collaboration and teambuilding skills. Good judgment and impeccable ethics; desire to succeed in a demanding, innovative, entrepreneurial environment. Exceptional organizational skills and keen attention to detail. Willingness to travel frequently within the U.S. Our benefits To help you stay energized, engaged and inspired, we offer a wide range of benefits including a strong retirement plan, tuition reimbursement, comprehensive healthcare, support for working parents and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about. Our hybrid work model BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock. About BlackRock At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress. This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive. For additional information on BlackRock, please LinkedIn: BlackRock is proud to be an Equal Opportunity and Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, disability, protected veteran status, and other statuses protected by law. BlackRock will consider for employment qualified applicants with arrest or conviction records in a manner consistent with the requirements of the law, including any applicable fair chance law. Create a job alert and receive personalised job recommendations straight to your inbox.

Associate Director, HR Business Partner - Endoscopy Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role: Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust product portfolio offers a variety of solutions, including but not limited to balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, radiofrequency ablation, and enteral feeding. We continue to innovate and invest in endoscopy treatments, both within established product lines and in future pipelines. This role reports directly to the Vice President of Human Resources for the Endoscopy division and will support R&D, Medical Affairs, Clinical, Regulatory Affairs, and Finance functions. You will work closely with COE partners and functional colleagues across the BSC HR matrix to align HR strategies with business objectives, ensuring our people remain our most valuable asset. Your leadership will help foster a culture of high performance, global collaboration, innovation, care, diversity, and a strong winning spirit. By providing guidance and expertise, you will enable teams to not only meet but exceed expectations, supporting our mission to advance science for life. Your commitment to creating a supportive and inclusive environment will help our employees thrive, reinforcing our organization's leadership in addressing the needs of patients and customers. Based in Marlborough, MA, the position follows a hybrid schedule, requiring 3 days per week onsite. Your responsibilities will include: HR Business Strategy: Collaborate with senior leadership to achieve business goals and objectives by implementing purposeful people and organizational design strategies. These initiatives are aligned with the specific needs of a highly matrixed organization, supporting both business growth and talent development. Workforce Planning:Develop and execute a comprehensive workforce plan across various locations. Anticipate future talent needs, proactively address potential shortages or surpluses, optimize resource allocation, and build a resilient, agile team. Talent Management: Develop and lead the talent agenda by creating plans to assess talent, conduct pipeline analysis, and address gaps to support internal development and mobility. Partner with senior leadership to build strategies for attracting talent to the organization. Building Culture:Partner with leaders to promote and integrate company values and behaviors, ensuring they are used to motivate and engage a high-performing global team. Diversity & Inclusion: Foster an inclusive and diverse workplace where all team members can contribute to their full potential and feel a sense of belonging while pursuing organizational objectives. Advise leaders on strategic initiatives to continuously enhance the organization's culture, diversity, and inclusion. HR Model Leadership: Collaborate with site HR teams, HR Centers of Excellence, and key stakeholders to deliver comprehensive and effective HR solutions to client groups. Advise clients on utilizing the appropriate HR channels (e.g., People Services, OneConnect). Provide leadership and mentorship to HR partners and peers while fostering a culture of collaboration, innovation, productive feedback, and continuous learning within the HR function. Organizational Design: Partner with business leaders to assess organizational needs and develop solutions that enhance performance, productivity, and team effectiveness. Lead change management initiatives and cultivate a culture of continuous improvement. Endoscopy HR Team: Actively contribute to the Endoscopy HR team by supporting division-wide HR initiatives and occasionally representing the Endo division on global and company-wide projects. Coaching & Mentoring:Serve as a coach and mentor to leaders, establishing yourself as a credible advisor Required Qualifications: 10+ years of progressive human resources experience, preferably in a similarly sized global organization. Ability to travel up to 10% to other sites as needed to support business objectives. Strong business acumen with proven, in-depth experience in assessing, identifying, designing, and implementing talent management and organizational effectiveness initiatives. Excellent analytical skills, with the ability to leverage insights to inform forward-thinking strategies for talent and organizational evolution. Proven relationship-building and influencing skills, with a strong track record in both. Demonstrated ability to address highly complex business challenges, managing both urgent short-term issues and long-term strategic priorities. Deep understanding of talent acquisition and development, with experience in creating and deploying effective engagement and retention strategies. Strong commitment to defining and delivering diversity and inclusion strategies. Experience in guiding, coaching, and advising senior executives as a credible business partner. Excellent communication skills with the ability to build strong networks. Demonstrated experience as an active sponsor, mentor, and/or coach of talent. Preferred Qualifications: Demonstrated cultural agility with the ability to effectively lead and collaborate globally across divisions, regions, and functions. Self-directed work style, with the ability to work independently, delivering results with a customer focus and a strong sense of urgency. Experience in developing and implementing workforce planning strategies. Current or previous experience at Boston Scientific. Requisition ID: 590907 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class. Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Nearest Major Market: Boston Job Segment: Surgery . click apply for full job details

Senior Director, Nonclinical Safety (Toxicology) Nimbus has an outstanding opportunity for a Senior Director of Nonclinical Safety (Toxicology) to join our growing organization. Serving as the function head, this role will lead the nonclinical safety strategy and execution for programs across discovery, nonclinical, and clinical stages. This role will also oversee aspects of investigative toxicology, strategic review and interpretation of all non-GLP and GLP toxicology studies, the nonclinical safety budget, and collaborate with team members, project teams, and external partners to ensure alignment and drive excellence in nonclinical safety practices. You will report to our Senior Vice President of Nonclinical Sciences. In This Role, You Will: Develop the strategy of nonclinical development plan in collaboration with internal and external stakeholders Propose and implement project-specific nonclinical toxicology study design (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines and goals Oversee the selection and management of consultants and CROs. Manage nonclinical safety studies conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, demonstrate the ability to interpret the data, review draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities. Prepare all nonclinical safety-relevant documents to support regulatory filing including IND, IND annual updates, IB, and DSUR, as well as briefing books for US, EU, Japan, and International regulatory meetings and filings Respond with scientifically robust rationale to questions from US FDA, EU, Japan, and other health authorities in support of development programs As a study monitor, direct and oversee nonclinical toxicology studies including but not limited to genetic toxicology, safety pharmacology, general toxicology, and development and reproductive toxicology studies supporting nonclinical and clinical development programs Ensure compliance with global nonclinical toxicology studies as per regulatory guidelines Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of new small molecule drug entities Provide leadership and management support that can build and inspire our team and drive collaboration and innovation Represent Nonclinical Safety at cross-functional project and safety teams as well as leadership teams/reviews These Qualifications Will Help This Role Be Successful: PhD and/or DVM in Toxicology or related health discipline with 15+ years of toxicology experience in the pharmaceutical and/or biotechnology industry. DABT or DACVP/FIATP certification is valued but not required Experience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs from IND/CTA submission through various clinical development phases. Experience with NDA/MAA submission is a plus Demonstrate knowledge and full understanding of GLP regulatory requirements and providing responses to the FDA Strong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationships Ability and interest in leading project team member(s) Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams Attention to detail quality and compliance Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment Join Nimbus. We are making a difference and you can too. At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation. Responsibilities: Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues. Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision. Health Authority Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives. Qualifications: Education and Experience: Bachelor's Degree in Life Science required. M.S./PhD. preferred in a scientific discipline. MS Degree with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or PhD. with 6-8 years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experience Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced knowledge of regulations/guidance documents with strong technical knowledge based upon academic training and job experience. Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas. Travel Ability to travel up to 10%, Global Travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Our location in Alameda, California, currently has an opportunity for a Senior Manager, Public Affairs - Diabetes Care. The Public Affairs function for Abbott's diabetes care business has global responsibility for public relations activities for the world-leading sensing technology platform including FreeStyle Libre for people with diabetes and Abbott's Libre Sense Glucose Sport Biosensor designed for athletic performance. The successful candidate is passionate about consumer technology and its impact on human health. Seeking a candidate who is a strong storyteller in consumer, tech, and health, and has a proven-track record of top-tier media relations skills, can create compelling internal and external content, manage and anticipate crisis and issues, and develop international PR programming. The candidate will be self-motivated and nimble, thrive in a fast-paced dynamic environment, and have experience in supporting and executing successful PR and communications programs. Seeking a candidate with an ability to manage multiple projects across time zones, experience in working with other PR teams, agencies and has experience in managing crisis scenarios (pro-active and reactive), and supporting employee communications. The position will report directly to the the Head of Public Affairs for Abbott's diabetes care business. All division PA functions have a line reporting relationship to Corporate Public Affairs. WHAT YOU'LL DO Provide strategic counsel to marketing groups, internal/external clients, and country-level leadership on business-related efforts and initiatives; partner with various stakeholders including regulatory affairs, operations, quality, R&D, HR, government affairs, investor relations, legal, finance and senior management. Support the development and execution of external public relations strategies and approaches for key global product launches/filings, key clinical and real-world data, product awareness programs/outreach and influencer programming. Work extensively with U.S. and international business, including affiliates and public affairs colleagues outside of the U.S. as well as agency partners. Assist director in developing plans, content, and supporting communication needs of country managers and affiliates around the world. Oversee PR agency management and/or PR agency selection process as needed. Work extensively with top-tier business, technology, lifestyle and consumer reporters (both proactively and reactively) to enhance and protect the company's reputation as well as advance business objectives. Develop compelling consumer-focused storylines, positioning and key messaging for the business. Assist with executive communications strategy and development of internal communication materials. Identify and anticipate issues and working with appropriate functions to counsel management on reputation/business impact and influence business decision making process. Develop multimedia, content and social and digital strategies to complement key Public Affairs campaigns. Bring to the table an understanding of today's communications environment amongst earned, owned, social and paid media and how to align and maximize opportunities provided by these channels for Abbott's glucose sensing technology. Set metrics to measure effectiveness of internal and external communication efforts. Coach senior divisional executives, businesses, regions and third-party spokespeople on delivery of key messages. EDUCATION AND EXPERIENCE YOU'LL BRING Required A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. 7+ years of experience in public relations and media relations, with a deep understanding of how to use external communications to enhance reputation. Preferred Experience in healthcare, technology and/or direct-to-consumer communications preferred. Strong contacts and working relationships with a variety of top tier media. Proven ability in placing media stories and managing relationships with U.S. top-tier technology, lifestyle, consumer and business media; experience with international media and media landscapes. Consistent track record of excellent professional writing, communication and project management skills. Strong experience in developing compelling content for product communications and developing key positioning, messaging, toolkits. Experience in working in a regulated environment. Able to achieve results while dealing with ambiguity, discretion, and a rapid pace of change. Experience working with and counseling senior management. Exhibits strong judgement and executive presence. Experience in crisis communication and exhibits anticipatory thinking. Proven experience in leading digital, social media and influencer projects to build brands. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on

Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE