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
- ...Description Retro develops therapies for diseases driven by... ...to rejuvenate cell and tissue function with... ...experienced new member of our Regulatory team who will own the... ..., and Controls (CMC) regulatory work. As one... ...role is approximate to Director level. Total compensation...Suggested
- ...Inc. is a clinical stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategies and submissions in early to late-stage development, supporting...Suggested
$194k - $199k
Overview About Summit Summit Therapeutics Inc. is a... ...clinical studies, including: Regulatory Studies Non-small Cell Lung Cancer (NSCLC)... ...is an investigational therapy not presently approved... ...Of Role The Associate Director, Regulatory Affairs, CMC is responsible for coordinating...SuggestedWork 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...SuggestedFull 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...SuggestedFull timeFor contractorsLocal area$130k - $179k
...developing allogeneic gamma delta T cell therapies for autoimmune diseases and... ...our website at Manager, Regulatory Affairs Adicet Bio is... ...responsible for managing the global CMC regulatory implementation of... ..., age, or veteran status. #J-18808-Ljbffr Initial Therapeutics, Inc.Full timeTemporary workWork at officeFlexible hours3 days per week$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$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... ...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$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...
- Summit Therapeutics in Palo Alto, CA, seeks an Associate Director for Regulatory Affairs, focusing on Chemistry, Manufacturing, and Controls (CMC) to coordinate global regulatory filings. The ideal candidate will have 6+ years of experience in regulatory CMC and knowledge...
- 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...
- ...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$211k - $250k
...developing next-generation therapeutics for genetic... ...Portal is developing a novel potential best-in-class therapy for erythropoietic... ...Who You Are A regulatory affairs leader who... ...clinical, nonclinical, CMC, biometrics, safety... ...for Associate Director; 8 years for Director...Flexible hours$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... ...development and global registration of therapeutic products and associated companion...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$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- ...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
- ...delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are... ...to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform... ...patients with cancer. Overview The Manager, Regulatory Affairs, represents Regulatory Affairs...Work at officeRemote work
$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$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$194k - $199k
Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor's degree in Chemistry or related field, at least 6 years of Regulatory CMC experience, and thorough...Work at office$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$302.01k - $390.83k
...working relentlessly to develop therapies that help improve lives and to ensure... ...OVERVIEW:The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading... ...driven development across all Gilead therapeutic areas. This role ensures seamless...Full timeFor contractorsWork at officeLocal areaFlexible hours$244k - $305k
...Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D... ...and program management for probability of technical and regulatory success (PTRS).Foster a culture of collaboration,...Full timeLocal area
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