Global CMC Regulatory Lead — Cell & Gene Therapy
Senti Biosciences
Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San Francisco. You will shape regulatory strategies, optimize processes, and ensure alignment with industry standards. Strong leadership, communication, and program management are essential for success in this role. #J-18808-Ljbffr Senti Biosciences
- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B... ...extensive experience in biologics and gene/cell therapy. Some travel (approx. 20%)...Regulatory
- ...an experienced Scientific Project Management leader to drive global project management and to guide the regional strategy for GPT cell therapy initiatives. You will lead and develop a team, ensure regulatory compliance, and coordinate with cross-functional partners to...Regulatory
- Provides expertise through global project management or by managing... ...Management perspective Leads, guides, evaluates and develops... ...business benefit Leads the GPT for cell therapy which is accountable to... ...coupled with the appropriate regulatory and commercial insights A deep...RegulatoryHourly payTemporary work
- ...Therapeutics in South San Francisco, CA, seeks a Senior Manager / Associate Director, Regulatory Affairs to guide regulatory strategy across clinical and CMC for ATMPs. You will lead submissions (IND/CTA/BLA/MAA), interact with health authorities, and shape regulatory...Regulatory
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and excellent technical writing skills...Regulatory- ...Myers Squibb is seeking a Senior Manager, Global Clinical Scientist (Cell Therapy) to design and deliver clinical trial activities. You will lead cross-functional teams, liaise with... ...and contribute to study reports and regulatory submissions, advancing cell therapy programs...Regulatory
- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role... ...regulatory knowledge, organizational skills, and the ability to lead cross-functional projects. Candidates should have at least 6...Regulatory
- ...Squibb is seeking a Senior Manager, Global Clinical Scientist (Cell Therapy) to design and oversee clinical... ...will partner with clinical teams, lead trial level activities, and support... ...ability to develop study protocols and regulatory documents, while driving data quality...Regulatory
- ...Biotherapeutics aims to be the global leader in innovating... ...lymphocyte (TIL) therapy for people with... ...diverse cancer cells in each patient. The... ...therapy, including gene-edited cell therapy,... ...Overview The Director, Regulatory CMC, is responsible for leading one or more drug development...RegulatoryWork at officeRemote work
- ...is seeking a Principal Scientist in South San Francisco to lead cell therapy drug product process development. You will design and execute... ...improvements, and collaborate across gRED, CTED, ADQC, MSAT, and Regulatory groups. The role requires 7-10+ years in pharmaceutical...Regulatory
$211k - $264k
...oncology company developing novel targeted therapies for patients with RAS-addicted... .... The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation... ..., Clinical, Biostatistics, CMC, Quality, Translational Medicine and...RegulatoryFull timeWork experience placementLocal area$244k - $305k
...oncology company developing novel targeted therapies for patients with RAS-addicted cancers... ...: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory... ...Clinical Development, Biometrics, and CMC to deliver high-quality global...RegulatoryFull timeLocal area- ...biopharmaceutical company in seeking a Senior Director, Regulatory Affairs, CMC. This lead CMC regulatory expert role partners with Regulatory Affairs, Technical Operations, and Development teams to drive global CMC strategy and execution through late-stage development...Regulatory
- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs.... ...teams to develop regulatory strategies and prepare global submissions. The role requires strong scientific writing,...Regulatory
$173.1k - $321.5k
...Strategy in support of our Cell Therapy portfolio. In this role... ...to inform development, regulatory, and portfolio... ...Clinical Development, CMC, Regulatory, and Computational... ...Sciences project leads to developing integrated... ...iPSC-derived products, gene-edited cellular therapies...RegulatoryFull timeLocal areaRelocation package- ...South San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-functional execution, and... ...acumen, and ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC Pharmaceuticals Inc.Regulatory
$104.7k - $194.4k
...Genentech’s Pharma Technical Cell & Gene Therapy organization, we ensure the... ...stem cell biology. You will lead initiatives aimed at understanding... ...or a related fieldYou have CMC Experience - a proven track... ...assays within a CMC/regulatory framework (understanding phase...RegulatoryFull timeLocal areaRelocation packageShift work- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams...Regulatory
- ...Seattle-based company leading the development of adoptive T-reg therapies cell for autoimmune and... ...an experienced Regulatory professional to... ...participate in design of global regulatory... ...counterparts (Reg CMC and Reg Ops) and collaborate... ...ideally in cell & gene therapy Well-...RegulatoryRemote work
- ...the latest breakthroughs in cell therapy, this is work that transforms... ...with-us .The Senior Manager, Global Clinical Scientist provides scientific... ...serve as Clinical Trial Lead for one or more trialsMay... ...CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR,...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
$173.39k - $210.11k
Senior Manager, Global Clinical Scientist (Cell Therapy) - R1603793 Overview Challenging. Meaningful. Life‑changing... ...May serve as Clinical Trial Lead for one or more trials May lead or... ...reports (CSRs) and clinical portions of regulatory documents (e.g., IB, DSUR, PSUR,...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$245k - $285k
...candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes... ...and activities for a complex cell therapy product on a global basis. The successful candidate... ...-appropriate compliance of gene and cell therapy pipeline of...RegulatoryContract work$104.7k - $194.4k
...ADQC) team, part of the Pharma Technical Cell & Gene Therapy organization, is expanding. The team... ...commercial release. Responsibilities Lead initiatives to understand metabolic rewiring... ...Experience developing assays within a CMC/regulatory framework (phase‑appropriate...RegulatoryLocal areaRelocation package- ...pipeline of first-in-class therapies to address genetically... .... The company’s lead program, MAR001, is being... ...motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...products in the US and globally. The incumbent will be...RegulatoryFull timeWork at office2 days per week
$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San Francisco, Californiatime... ..., clinical supply chain, CMC, quality, regulatory, program & portfolio management.This... ..., Research & Non-clinical Development; Global Supply Chain & Technical Operations;...Regulatory$161.93k - $243.5k
...DescriptionSetidegrasib Launch Lead (NSCLC), US... ...Astellas Astellas is a global life sciences company committed... ...provide transformative therapies in disease areas that... ...(A3082) in non-small cell lung cancer, a key oncology... ...with medical, legal, regulatory, market access, sales,...RegulatoryWork at officeRemote workWork from homeWorldwideFlexible hours- Erasca, Inc. is seeking a Senior Manager or Associate Director of CMC Regulatory Affairs to lead regulatory activities for IND/CTA development, with future MAA/NDA/BLA planning. This high-profile role requires an independent, self-directed regulatory professional with...Regulatory
- ...Manager, Clinical Product Supply to ensure high‑quality clinical materials and regulatory compliance across drug substance, product, and finished product stages. You’ll lead the RDQA interface with CMC teams and external partners to preempt risks and drive timely releases....Regulatory
- Genentech, a member of the Roche group, seeks a Regulatory Innovation & Sustainment Professional to lead or support cross-functional efforts in Quality & Compliance, ensuring global standards and readiness for regulatory inspections. You will maintain the QMS framework,...Regulatory
- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory... ...project lead. The role involves overseeing global Health Authority interactions, leading...Regulatory
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