Director, Regulatory Affairs
Lyell Immunopharma · Seattle, WA +1 more
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Role summary
Lyell Immunopharma seeks a Director of Regulatory Affairs to lead global regulatory strategy for next-generation CAR-T cell therapies in oncology. The role involves developing and executing comprehensive regulatory strategies from early clinical stages through product licensure, serving as primary liaison to health authorities including the FDA and EMA, and managing critical regulatory submissions and milestone achievement. Based in Seattle, WA or South San Francisco, CA.
What they're looking for
- Extensive experience developing global regulatory strategies for cell therapy or oncology programs
- Proven track record managing FDA and EMA interactions through IND, BLA, MAA submissions
- Deep knowledge of CAR-T cell therapy regulatory pathways and evolving requirements
- Cross-functional leadership experience coordinating CMC, clinical, and commercial teams
- Strong negotiation and communication skills with regulatory agencies and internal stakeholders
What you'll be doing
- Define and execute global regulatory strategies for CAR-T programs from clinical development through licensure
- Serve as primary liaison to FDA, EMA, and other health authorities for meetings and submissions
- Lead preparation of regulatory dossiers including IND, CTA, BLA, and MAA applications
- Identify regulatory risks, develop mitigation plans, and anticipate challenges in CAR-T landscape
- Collaborate across CMC, clinical development, and medical affairs teams on regulatory alignment
Privacy & handoff
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