Global Regulatory Lead - CAR-T Cell Therapies
Lyell Immunopharma
Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define and execute the global regulatory strategy for CAR‑T programs from early development through licensure. You will serve as the primary regulatory representative to global health authorities (FDA, EMA), ensuring alignment with clinical, CMC, and development plans. You will lead cross‑functional teams, review key regulatory documents, mentor staff, and drive major submissions (IND/CTA, BLA/MAA) while #J-18808-Ljbffr Lyell Immunopharma
- ...Development, Haematology and Cell Therapy About the Company... ...responsible for defining and leading the global clinical development strategy... ...clinical trials, and leading regulatory strategy and global health... ...cellular therapies such as CAR-T and NK. The role requires...CarRegulatory
$173.1k - $321.5k
...Bioanalytical Strategy in support of our Cell Therapy portfolio. In this role, the... ...to inform development, regulatory, and portfolio decisions... ...Bioanalytical Sciences project leads to developing integrated... ...cell therapy products, such as CAR-T, TCR-T, TILs, iPSC-derived...CarRegulatoryFull timeLocal areaRelocation package$103.4k - $192k
The PositionThe Cell Therapy department within Genentech Research and Early Development (gRED... ...demonstrated through publications, patents, regulatory submissions or meaningful contributions... ...analysis tools.Experience developing CAR-T, TCR-T or other engineered T cell therapies...CarRegulatoryFull timeLocal area$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs...RegulatoryHourly payTemporary workWorldwideFlexible hours3 days per week- ...Executive Director, Regulatory Affairs About the Company... ...Specialties cell therapy autoimmune and lupus... ...myasthenia gravis car t-cell and stiff-person... ...defining and executing global regulatory strategy to... ...including the FDA, and will lead and support key...CarRegulatory
- ...in California, seeks a Senior Principal Scientist to lead the Bioanalytical Strategy for Cell Therapy. You will define integrated data strategies to answer key scientific questions and inform development, regulatory, and portfolio decisions across programs. You will partner...Regulatory
$270.19k - $405.28k
...Clinical Operations, Program Management (Cell Therapy/ Car-T)Locations: US based (Gaithersburg,... ...to role: Are you ready to lead global cell therapy clinical operations across... ...agreed time and cost, meeting quality and regulatory standards across the portfolio.Governance...CarRegulatoryHourly payFull timeTemporary workWork at officeFlexible hours3 days per week- ...Executive Director, Lifecycle Lead About the Company Esteemed... ...Specialties cell therapy autoimmune and lupus... ...scleroderma myasthenia gravis car t-cell and stiff-person syndrome... ...to manage stakeholders, drive global programs, and foster innovation...Car
- Role Serve as R&D project lead for external opportunity due diligence, focusing on clinical... ..., and synthesize scientific, clinical, regulatory, and financial data into strategic... ...supporting licensing and partnership decisions; global collaboration. WorkSetup hybrid model in...RegulatoryWork at office
- ...join our Clinical Operations team in California. You will oversee global trials, manage CROs and service providers, and coordinate cross... ...SCTM collaborates with teams in the US and Shanghai, supports regulatory readiness, and ensures SOP compliance. #J-18808-Ljbffr...Regulatory
- ...our pioneering personalized CAR T-cell therapies have changed the paradigm.... ...Biostatistics will play a leading role in contributing to short... ...product development plans, global submission plans and... ...(GCP), ICH guidelines, and regulatory requirements.Applies a strong...CarRegulatoryFull timeTemporary workFor contractorsWork at officeLocal areaRemote work
$85 - $96 per hour
...management - in support of Clinical Development, Drug Safety, and Regulatory. It is also the primary owner of clinical trial site budgets... ...outsourcing; experience with oncology trials, including cell therapy, CAR T, or other complex trial experience is preferred Working...CarRegulatoryContract work$146.54k - $189.64k
...scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join... ...(NDA/BLA) submitted to the FDA, EMA, and other global regulatory agencies.Collaborate closely with scientists and clinicians...CarRegulatoryFull timeFor contractorsLocal area$281.01k - $363.66k
...our pioneering personalized CAR T-cell therapies have changed the paradigm. But... ...as the clinical development lead from early development... ...brochures, clinical study reports, regulatory documents, and other key... ...Experience leading interactions with global health authorities and...CarRegulatoryLocal area$200k - $300k
...unified payments and financial platform for global businesses. Powered by our unique... ...Valued at US$11 billion and backed by world-leading investors including T. Rowe Price, Visa,... ...Chief Revenue Officer (“CRO”), Chief Regulatory and Compliance Officer (“CRCO”) and senior...RegulatoryTemporary workLocal areaWorldwide$255k - $335k
...chimeric antigen receptor T cell (AlloCAR T) products... ...experience in cell therapy, Allogene is developing... ...pipeline of "off-the-shelf" CAR T cell product... ...Medical Director will lead the execution of an oncology... ...translational science, regulatory affairs, drug safety, biostatistics...CarRegulatoryFull timeInternshipWork at officeLocal areaRemote work- ...Role: Global Clinical Program Lead, Hematology Hybrid Working: Minimum of 3 days per week in the... ...Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet... ...trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials)....RegulatoryHourly payTemporary workWork at office3 days per week
- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco... ...includes developing strategies for first-in-class therapies and ensuring clear communication with global health authorities. The candidate should be self-...Regulatory
- Genentech is looking for a PDQ Principal Quality Lead in South San Francisco, CA. This role requires a seasoned quality professional... ...quality strategies, manage audits, and ensure compliance with regulatory standards. Applicants should have at least 10 years in the pharmaceutical...Regulatory
- ...leader to provide strategic and tactical medical leadership for global development programs, ensuring safety and regulatory compliance from early research through approval and launch. This executive will lead program teams across Clinical Development, Research and...Regulatory
- ...Francisco seeks an Associate Director, Supply Chain Operations to lead end-to-end global product planning, procurement, and logistics. You will... ...with Clinical, Commercial, Development, Finance, Manufacturing, Quality, and Regulatory teams. #J-18808-Ljbffr BioSpaceRegulatory
$168.22k - $203.84k
...production line to the latest breakthroughs in cell therapy, this is work that transforms the lives... ...Current working knowledge of US legal, regulatory, and compliance regulations and... ...bereavement, and military needs and an annual Global Shutdown between Christmas and New...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Global Clinical Trial Leader (Hybrid) South San Francisco, United States | Posted on 09/08/2026 Our client, a worldleader in life sciences... ...Phase I/II clinicaltrials. Knowledgeof GCP/ICH, international regulatory requirements, and end-to-end drugdevelopment. #J-18808-Ljbffr...RegulatoryContract work
$90 - $98 per hour
...Description Job Description Job Title: Global Clinical Trial Leader Location: South... ...Francisco, CA on a hybrid schedule. This role leads execution and delivery of early-phase... ...knowledge of GCP/ICH requirements, international regulatory guidelines, and drug development...RegulatoryContract workLocal areaFlexible hours$200k - $230k
...Leader (PQL) to oversee Allogene’s CAR T programs, including starting materials (cell starting materials, viral vectors... ...in the allogeneic cell therapy space. The role will entail oversight... ...registration documents and submissions to regulatory agencies. Partners and aligns...CarRegulatoryContract workWork experience placementWork at officeLocal area$220k - $300k
...Finance USA Using living cells to treat - and... ...successfully treated with cell therapies. However, these... ...pipeline of next-generation CAR T-cell therapies for patients... ..., and ensuring regulatory compliance. KEY ROLE AND... ...progress top of mind; Lead, develop and execute a...CarRegulatoryWork at officeLocal areaShift work- ...world leader in biotechnology and life sciences, is looking for a "Global Clinical Trial Leader" based out of South San Francisco, CA (... ..., operational excellence, and compliance with GCP/ICH and regulatory requirements. Key Responsibilities Provideoperational leadership...RegulatoryLong term contract
- ...Executive Director, Global Medical Affairs Lead, Oncology About the Company Innovative biopharmaceutical company Industry Pharmaceuticals... ...are in line with the company's strategic objectives and regulatory requirements. This pivotal role demands a leader with a...RegulatoryRemote work
- ...Therapeutics Specialties cell therapy autoimmune and lupus... ...scleroderma myasthenia gravis car t-cell and stiff-person... ...sales strategy, building and leading a high-performing specialty... ...ensuring compliance with regulatory and company requirements. The...CarRegulatory
$254k
...WalmartBusiness Segment: Home OfficeDefine the Global Fraud, Identity, and Account Protection... .... Build the Future of Trust and Commerce Lead the development of modern fraud... ...global products across multiple markets, regulatory environments, and customer segments. Knowledge...RegulatoryFull timeTemporary workPart timeWorldwide
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