Regulatory Affairs Lead — Cell Therapies
Neurona Therapeutics
Neurona 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 pathways while collaborating with cross-functional teams. The role requires a PhD in a relevant field and 4+ years (Senior Manager) or 6+ years (Associate Director) of regulatory affairs experience, with preference for #J-18808-Ljbffr Neurona Therapeutics
- 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...Suggested
- ...Scientific Project Management perspective Leads, guides, evaluates and develops the team... ...business benefit Leads the GPT for cell therapy which is accountable to deliver and execute... ...development process, coupled with the appropriate regulatory and commercial insights A deep and broad...SuggestedHourly payTemporary work
- Genentech in California is seeking an accomplished leader to advance metabolomics and media optimization within the Cell Therapy Process Development team. You will drive development of chemically-defined cell culture media platforms for T cell and stem cell therapies,...Suggested
$90k - $210k
Cellares in South San Francisco is seeking an innovative Supervising Principal Scientist to lead process development in cell therapy. The role focuses on optimizing processes, driving continuous improvement, and managing teams. Ideal candidates should have 6-20 years of...Suggested- Genentech in California seeks a leader for metabolomics-driven cell culture media development within the Cell Therapy Process Development group. You will guide platform-level media programs for T cell and stem cell therapies, translating insights into scalable manufacturing...Suggested
- ...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...
- ...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 deliver strategic development plans...
- ...cancer - working relentlessly to develop therapies that help improve lives and to ensure... ...possible, together.Job DescriptionFUNCTION: Regulatory Affairs Business Operations - RA Human... ...indirect reports, with responsibility to lead other people managers. You will routinely...Full timeFor contractorsLocal areaWorldwide
$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... ...Approximately 12+ years of regulatory affairs experience within the biotechnology or...Full timeLocal area$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...Full timeWork experience placementLocal area$161.93k - $243.5k
...DescriptionSetidegrasib Launch Lead (NSCLC), US OncologyAbout... ...patients. We provide transformative therapies in disease areas that include... ...(A3082) in non-small cell lung cancer, a key oncology pipeline... ...with medical, legal, regulatory, market access, sales, training...Work at officeRemote workWork from homeWorldwideFlexible hours- ArsenalBio is seeking a Cell Therapy Specialist II to join the Technical Operations team for day-to-day GMP manufacturing activities in Hayward/SF sites. The role requires collaboration with Manufacturing, Process Development, Quality and other support teams, with a Tue...
- 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...
- Pharmaceutical Company is seeking a Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion) to provide strategic regulatory leadership for commercial materials and to lead cross-functional review committees. The role requires reviewing...
- Maze Therapeutics is seeking a Project Manager, Regulatory Affairs to strengthen regulatory planning, timelines, and cross-functional collaboration across development programs. You will work closely with Regulatory Affairs, Medical Writing, and Regulatory Operations to...
- AbbVie seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) to lead regulatory strategy development and execution for US and Canada products. You will coordinate with FDA, support filings, and advise cross-functional teams on regulatory issues...
- Nurix Therapeutics, Inc. is seeking a Director of Regulatory Affairs (Strategy, Immunology & Inflammation) to lead global regulatory strategy and execution across immunology programs. You will guide nonclinical and clinical submissions, coordinate with internal teams,...
$142k - $213k
...Description The Quality Systems and Compliance Lead drives quality excellence at Verily by... ...standards of quality, reliability, and regulatory compliance. Responsibilities Leads the... ...experience in quality assurance or regulatory affairs within the medical device, digital health...Full time$111k - $167k
...more personalized, predictive, and precise. Description The Regulatory Compliance Lead is a technically grounded individual contributor... ...quantitative field with 5+ years of experience in regulatory affairs within the medical device, digital health, or life sciences...Full time$210k - $250k
Lead, Oncology and Translational Medicine, is a key scientific leader and integral member... ...path, enabling IND studies, and regulatory filing is required. Responsibilities: Directs... ...discovery research into novel cancer therapies, enable novel biomarker and clinical trial...- ORIC Pharmaceuticals is seeking a motivated Regulatory Affairs professional to join our team and advance the clinical development of oncology products. The role involves collaborating across regulatory operations, quality, CMC, nonclinical and clinical functions to support...
- Acadia Pharmaceuticals is seeking an Associate Director for Regulatory Affairs Project Planning & Coordination. This role involves developing and implementing project plans, ensuring regulatory strategy execution, and overseeing regulatory submissions both pre- and post...Work at office
- ...Executive Director, Lifecycle Lead About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases... ...Life Science Therapeutics Specialties cell therapy autoimmune and lupus lupus multiple sclerosis systemic...
$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...- Nurix Therapeutics, located in Brisbane, CA, is seeking a Senior Manager, Regulatory Operations to join the Regulatory Affairs team. You will coordinate submissions in Veeva RIMS, compile documents for US FDA and global health authorities, and ensure regulatory compliance...
- ORIC Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...
$184k - $253k
...for 7-9 Family Access Managers. You will develop, coach, guide, manage and lead this patient-facing team within the commercial neuromuscular business to help patients start and stay on therapy. Under your leadership, the team will continue building strong relationships...Full timeTemporary workLocal area- 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... ...least 10 years of experience in regulatory affairs, strong strategic skills, and the ability...
- ...cancer - working relentlessly to develop therapies that help improve lives and to ensure... ...Development whose mission is to achieve regulatory approval and successful marketing of new... ...Oversight Statistical Programming (AOSP) Lead is essential to these partnerships. As a...Full timeFor contractorsLocal area
$129.6k - $194k
...A Day in the Life Join Thermo Fisher Scientific as a Lead Account Manager and contribute to growth through consultative sales... ...management, you'll help advance the delivery of life-changing therapies to patients worldwide. We offer a dynamic environment where you...Contract workTemporary workWork at officeWorldwide
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