Regulatory CMC Director Cell Therapy Strategy Submissions
Bristol Myers Squibb
Scorpion Therapeutics is seeking a Director of Regulatory CMC for Cell Therapy to lead global regulatory strategy and submissions across development and lifecycle stages. The role focuses on cell therapy programs, with emphasis on advanced therapies and biologics, requiring collaboration with cross-functional teams at a global level. On-site or hybrid work arrangements are available, with travel up to 5%, and a leadership role in regulatory submissions and strategy development. #J-18808-Ljbffr Bristol Myers Squibb
Vacancy posted 2 days ago
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- Role: The Director of Regulatory CMC for Cell Therapy oversees management of multiple development and lifecycle projects, representing... ...and communicating global regulatory strategies, preparing and reviewing CMC submissions, ensuring compliance, and supporting external...Suggested
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Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction... ...and Health Authority interactions through major submissions and post-approval maintenance—helping the business...SuggestedHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per weekAstraZeneca
Gaithersburg, MD4 days ago- ...AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy... ...interactions from expedited designations to major submissions, ensuring patient value and global #J-18808-...Suggested
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Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and... ...strategyContributes to the review, authorship and quality of regulatory submission documents and Health Authority communicationsCounsels and...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Washington DC2 days ago- AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You will lead regional regulatory initiatives across development, submission, approval and lifecycle management in a global...Suggested
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Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential of cell therapy for people... ...with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a high...Full timeTemporary workWork at officeFlexible hours3 days per weekAstraZeneca
Gaithersburg, MD2 days ago- ...Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in... ..., MD for a 100% hands-on CMC role. The position is hybrid with onsite... ...You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams...
- ...AstraZeneca GmbH seeks a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will shape end-to-end strategy for a therapeutic indication, lead global commercial initiatives, and align with clinical, data science, and market access...
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...Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs... ...format and accountability for regulatory submissions and related supplements and... ...technical data in partnership with RA CMC and verifies accuracy of clinical data...Permanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Bethesda, MD1 day ago- AstraZeneca in Gaithersburg, MD seeks a Director, Patient Services Strategy for US Cell & Gene Therapy to build the patient services approach from concept through execution. This role collaborates across Brand Marketing, Market Access, Commercial Operations, Medical, Digital...
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Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week) Remote is not available for this role. The Director, Patient Services Strategy, US Cell & Gene Therapy, will build the patient services strategy for AstraZeneca...Hourly payTemporary workWork at officeRemote work3 days per week$145k - $213k
...to the Role At AstraZeneca Cell Therapy, we are building the capabilities... ...delay across borders. The Director, Cell Therapy Trade... ...Chain, Manufacturing, Quality, Regulatory, Finance, Procurement, Digital... ...trade compliance operations strategy and operating model for import...Hourly payTemporary workWork at officeFlexible hours3 days per week$268.2k - $402.2k
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Vacancy Name Director, Regulatory Affairs-Global Regulatory... ...and tactical strategy development, IND development/submission /maintenance, BLA/... ...trial labelling and CMC submissions for regulatory... ...-stage T cell receptor biotechnology... ...-class biological therapies to patients, we...Full timeWork at officeLocal areaRemote workWorldwideNight shift$140.2k - $390.6k
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...AstraZeneca seeks a Director to develop and execute the US patient services strategy for its cell and gene therapy portfolio. This role involves designing support models across complex treatment pathways, leading cross-functional teams, and advancing launch readiness...- Overview Manager, Regulatory Affairs US Remote Emmes... ...leading capabilities in cell and gene therapy, vaccines and infectious diseases... ...Affairs is a regulatory strategy leader who advises both... ...regulatory operations to ensure submissions are well-organized, on...Casual workLocal areaRemote workWork from homeFlexible hours
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Washington DC2 days ago- Overview Director, Government Operations Strategy (Operational Strategy Lead) Be Part of One Team, One Purpose... ...led groundbreaking research in cell and gene therapy, vaccines, infectious diseases,... ...(e.g., central laboratory, regulatory support, etc.). Supports BD/Capture...For subcontractorCasual workLocal areaRemote workWork from homeFlexible hours
- ...AstraZeneca GmbH in the United States is seeking a Senior Regulatory Affairs Director to lead global regulatory strategy for complex products, driving rapid approvals and advantageous labeling. You will chair the Global Regulatory Sub-team with regional input, manage...
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- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team and its...
- ...impact at AstraZeneca by leading strategy for our industry-leading... ...and deliver cutting‑edge therapies that improve patient outcomes... ...eradicating cancer. As Executive Director, Oncology Business Unit (OBU... ...Thorough understanding of regulatory and pricing dynamics in...Hourly payTemporary work
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Gaithersburg, MD1 day ago - ...medicines and influence regulatory decisions that... ...Affairs Director, you will play a... ...executing US regulatory strategies that accelerate... ...transformative oncology therapies to patients... ...across development, submission, approval and... ...clinical development, CMC, labelling and...Hourly payTemporary workWorldwide
- ...AstraZeneca plc in Gaithersburg is seeking a Senior Director for Global Regulatory Digital Strategy. You will lead the development and implementation of a comprehensive digital strategy across Regulatory, working with IT, AI units and external partners to ensure delivery...
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The PositionThis role is a valuable part of our Customer Segment Strategy team, which is committed to maximizing patient access and delivering transformative therapies to those who need them most. As a member of this team, you will have the opportunity to collaborate closely...Full timeContract workWork experience placementLocal areaRemote workRelocation packageGenentech
Washington DC4 days ago
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