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
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Global Regulatory Lead - CAR-T Cell Therapies in South San Francisco, CA vacancy
- 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...Regulatory
- ...• Provides expertise through global project management or by managing... ...Management perspective• Leads, guides, evaluates and develops... ...~ Leads the GPT for cell therapy which is accountable to deliver... ...coupled with the appropriate regulatory and commercial insights ~...RegulatoryHourly payTemporary workSouth San Francisco, CA2 days ago
- ...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
$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$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$210k - $260k
...Director, Regulatory Affairs Using living cells to treat – and sometimes even cure –... ...successfully treated with cell therapies. However, these profound... ...of next-generation CAR T-cell therapies for patients... ...of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing...CarRegulatoryTemporary workLocal areaLyell Immunopharma
South San Francisco, CA14 hours ago- 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/C/D meetings, and ensure alignment with agency expectations across the organization...Regulatory
$170k - $240k
...motivated Director to lead enterprise client programs... ...experience in cell therapy manufacturing, personnel... ...development activities to enable regulatory filingServing as the... ...cell therapies (e.g. CAR-T, TCR, HSCs, CD34+)Experience... ...for cell therapies at global scale. Partnering with...CarRegulatoryFull timeFlexible hours$211k - $264k
...stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R... ...signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of...RegulatoryFull timeWork experience placementLocal area$244k - $305k
...-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline... ...pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for...RegulatoryFull timeLocal area- ...role Are you ready to lead the charge in groundbreaking... ...clinical studies? As a Global Study Director (GSD),... ...a pivotal role in the Cell Therapy Clinical Operations... ...compliance with SOPs, regulatory requirements, and ICH/GCP... ...solutions. - Cell therapy/CAR-T experience. - Global...CarRegulatory
- ...States is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will lead end-to-end strategy across indication-level portfolios, collaborate with global and TA teams, and shape PH3ID forecasts with industry-leading...
- ...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
- Lyell Immunopharma is seeking a Director of Regulatory Affairs/Global Regulatory Lead to define, develop, and execute global regulatory strategies for CAR-T programs from early development through licensure and lifecycle management. You will serve as the primary regulatory...CarRegulatory
$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 weekSouth San Francisco, CA2 days ago- AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Immunology) to lead regulatory planning and execution for on-market and development programs in the US and Canada. The role partners with cross-functional teams, interfaces with FDA...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- ...Biosciences in South San Francisco seeks an Associate Director, Supply Chain Operations to lead global product planning, procurement, and logistics. You will ensure material availability, regulatory compliance, and inventory optimization using ERP systems and advanced planning...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
- ...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
- 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
$240.94k - $291.96k
...location for the role is Princeton, New Jersey and hybrid onsite requirements. Expected Areas of Competence Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources...RegulatoryLocal area- ...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
- ...breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're... ...:Responsible for preparing regulatory submissions which require interactions... ...Participate in group meetings and local and global product submission team meetings and...CarRegulatoryFull timeFor contractorsWork at officeLocal areaImmediate startRemote workRelocationFlexible hours
$220k - $260k
...Clinical Science Using living cells to treat – and sometimes even... ...treated with cell therapies. However, these profound results... ...pipeline of next-generation CAR T-cell therapies for patients... ...trials — ensuring adherence to regulatory standards, Good Clinical Practice...CarRegulatoryContract workLocal areaLyell Immunopharma
South San Francisco, CA2 days ago$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston... ...to role: Are you ready to set the global regulatory direction for first-in-... ..., global patient access? This role leads the strategy for our most visible...RegulatoryHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$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...CarRegulatoryInternshipWork at officeLocal areaRemote workAllogene Therapeutics
South San Francisco, CA2 hours ago$230k - $270k
...chimeric antigen receptor T cell (AlloCAR T) products... ...experience in cell therapy, Allogene is developing... ...pipeline of “off-the-shelf” CAR T cell product... ...as a key leader for our lead program. You will be responsible... ...Research, Clinical, Regulatory, Ops Tech, and...CarRegulatoryLocal areaRemote work$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...CarRegulatoryFull timeContract workWork experience placementWork at officeLocal 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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Lead - CAR-T Cell Therapies. Be the first to apply!
Related searches
- food regulatory South San Francisco, CA
- regulatory engineer South San Francisco, CA
- regulatory South San Francisco, CA
- regulatory cmc South San Francisco, CA
- regulatory technician South San Francisco, CA
- clinical research regulatory South San Francisco, CA
- regulatory law South San Francisco, CA
- regulatory executive South San Francisco, CA
- regulatory scientist South San Francisco, CA
- regulatory contract South San Francisco, CA