CMC Regulatory Director, Cell Therapy & Novel Therapeutics
Retro
Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role in Redwood City reports to the Regulatory Affairs leader and will build out global CMC capabilities for INDs, CTAs, and amendments. You will lead cross-functional teams, liaise with health authorities, and help establish scalable CMC processes in a growing biotech focused on longevity research. #J-18808-Ljbffr Retro
- Retro is seeking an experienced Regulatory affairs professional to own strategy and operations for CMC regulatory work. You will lead global CMC plans and interact with... .... This onsite role in Redwood City drivescell-therapy programs and other modalities with speed and...Suggested
- Retro develops therapies for diseases driven by the biology of aging.... ...reprogramming and autophagy to rejuvenate cell and tissue function with the... ...experienced new member of our Regulatory team who will own the strategy... ...Manufacturing, and Controls (CMC) regulatory work. As one of...Suggested
- Retro is hiring an experienced Regulatory Affairs leader to own the strategy and operations for CMC regulatory work across cell therapies, small molecules, gene therapies, and AI-designed proteins. This onsite role is based in Redwood City and reports to the head of Regulatory...Suggested
- ...infiltrating lymphocyte (TIL) therapy for people with cancer. We... ...recognize and attack diverse cancer cells in each patient. The Iovance... ...with cancer. Overview The Director, Regulatory CMC, is responsible for leading... ...authority expectations for novel and complex oncology...SuggestedWork at officeRemote work
$186k - $233k
...Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R... ..., we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies...SuggestedFull timeWork experience placementLocal area$194k - $199k
...Summit: Summit Therapeutics Inc. is a biopharmaceutical... ...: Non-small Cell Lung Cancer (NSCLC)... ...is an investigational therapy not presently approved by any regulatory authority other than... ...: The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating...Work at office$210.38k - $272.25k
...cancer - working relentlessly to develop therapies that help improve lives and to ensure... ..., together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device... ...diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver...Full timeFor contractorsLocal area$157.59k - $203.94k
...cancer - working relentlessly to develop therapies that help improve lives and to ensure... ...DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device... ...threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver...Full timeFor contractorsLocal area$244k - $305k
...oncology company developing novel targeted therapies for patients with RAS-... ...pathway.The Opportunity:The Sr. Director, US Compliance will serve... ...commercialization activities for non-small cell lung cancer (NSCLC). The Sr... ..., and evolving legal or regulatory requirements.The successful...Full timeLocal areaShift work$250k - $300k
...CARegulatory Affairs - Regulatory Affairs /Regular, Full-... ...traditional allogeneic stem cell transplant has been the... ...next-generation cell therapies with the goal of... ...Position Summary: The Senior Director, Regulatory Affairs is... ..., global expansion, CMC Regulatory and other significant...Full timeLocal areaImmediate startRemote work- ...A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs...
$244k - $305k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted... ...pathway.The Opportunity:The Senior Director, Molecule Global Regulatory Lead will develop and execute global... ...Development, Biometrics, and CMC to deliver high-quality global submissions...Full timeLocal area$211k - $264k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted... ...signaling pathway.The Opportunity:The Director of Regulatory Affairs (US Filing Lead) is accountable... ...Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and...Full timeWork experience placementLocal area$244k - $305k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...and leadership of one or more therapeutic areas for late-stage oncology programs... ...Oversee the development of global regulatory therapeutic area and product strategies...Full timeWork experience placementLocal area- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical... ...company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. The Executive...
$211k - $264k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted... ...signaling pathway.The Opportunity:The Director, Regulatory Affairs Companion Diagnostics is accountable... ...and global registration of therapeutic products and associated companion...Full timeLocal area$244k - $305k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...pathway.The Opportunity:The Senior Director of Compliance Training will lead the... ...engaging, risk-based training aligned with regulatory requirements and industry best...Full timeLocal area- ...City, California, is seeking a Director of Quality Assurance... ...Operations team supporting CMC activities across clinical development... ...of gamma delta T cell therapies. The role requires extensive... ...collaboration with Manufacturing, Regulatory, and QA Systems to ensure quality...
$186k - $233k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted... ...pathway.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral... ..., Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and...Full timeWork at officeLocal area$186k - $233k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ....The Opportunity:The Associate Director, Compliance - Field Commercialization... ...industry trends, enforcement actions, and regulatory developments.Serve as a senior presenter...Full timeLocal area$180k - $210.5k
...activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the... ...EMA, Health Canada and ICH) guidelinesReports to: Executive Director, CMC RegulatoryLocation: San Carlos, CA / US RemoteWork Arrangement...$164k - $205k
...late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The... ...to maintain inspection readiness and regulatory compliance. This position reports to the Sr. Director, IS Quality, Risk & Compliance.Responsibilities...Full timeLocal area$166k - $195k
...demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project management, regulatory and CMC functions. Reporting to the Vice...3 days per week- ...oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-... ...the RAS signaling pathway. The Senior Director, Compliance will provide enterprise-... ...functions. Support Quality and Regulatory departments with compliance related to...Full timeWork at officeLocal areaRemote workRelocation
$150k - $189k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...Affairs, Clinical Development, Regulatory, Market Access, Patient Services, Finance... ...role will report to the Sr. Compliance Director.Key ResponsibilitiesCompliance...Full timeLocal area$265k - $331k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ....The Opportunity:The Executive Director, GxP Quality & Compliance is a senior... ...will ensure adherence to applicable regulatory requirements, industry standards, and...Full timeLocal area$186k - $233k
...Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D... ...in the RAS signaling pathway.The Opportunity:The Associate Director, Global Healthcare Compliance Operations is responsible for...Full timeLocal area$186k - $233k
...Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R... ...pathway. The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical...Full timeWork experience placementLocal area$186k - $233k
...clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ....The Opportunity:As an Associate Director, you will be responsible for the following... ..., Good Clinical Practices (GCP) and regulatory requirements.SME for Clinical...Full timeWork at officeLocal area$280k - $310k
...other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the...Local area
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