Director, Regulatory Affairs
Lyell Immunopharma
August 22, 2026
On-site
South San Francisco, CA
Corporate Functions
Key Role and Responsibilities
Global Regulatory Strategy & Leadership
- Develop and lead comprehensive global regulatory strategies for CAR-T cell therapy development and commercialization.
- Represent Regulatory in cross-functional meetings to align regional regulatory requirements, CMC, and clinical development plans.
- Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the CAR-T regulatory landscape.
- Ensure timely submissions and approvals of global regulatory dossiers (IND, CTA, BLA, MAA).
Health Authority Interactions
- Serve as primary point of contact and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and preparing briefing documents.
- Support regional teams in resolving regulatory issues to expedite clinical study country expansion.
Cross-Functional Collaboration
- Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs to align regulatory strategy with science and market access goals.
- Review and approve key regulatory documents (clinical protocols, investigator brochures, non-clinical reports).
- Coach and mentor junior regulatory staff and other RA team members.
Regulatory Intelligence
- Monitor and analyze emerging regulations, guidelines, and competitor intelligence in cell and gene therapy.
Preferred Education
- Bachelor’s degree in Life Sciences required.
- PhD, PharmD, or MD strongly preferred.
Preferred Experience/Skills
- 15+ years biopharmaceutical industry experience; at least 8 years Regulatory Affairs.
- Substantial cell and gene therapy experience (CAR-T or T-cell engaging modalities).
- Track record leading major submissions (IND/CTA) and experience preparing BLA/MAA.
- Proven ability to interact and negotiate with regulatory authorities.
- Deep knowledge of FDA ATMP regulations.
- Strategic thinking; strong communication and negotiation; ability to work in complex, matrixed, fast-paced environments.
Global Regulatory Strategy & Leadership
- Develop and lead comprehensive global regulatory strategies for CAR-T cell therapy development and commercialization.
- Represent Regulatory in cross-functional meetings to align regional regulatory requirements, CMC, and clinical development plans.
- Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the CAR-T regulatory landscape.
- Ensure timely submissions and approvals of global regulatory dossiers (IND, CTA, BLA, MAA).
Health Authority Interactions
- Serve as primary point of contact and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and preparing briefing documents.
- Support regional teams in resolving regulatory issues to expedite clinical study country expansion.
Cross-Functional Collaboration
- Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs to align regulatory strategy with science and market access goals.
- Review and approve key regulatory documents (clinical protocols, investigator brochures, non-clinical reports).
- Coach and mentor junior regulatory staff and other RA team members.
Regulatory Intelligence
- Monitor and analyze emerging regulations, guidelines, and competitor intelligence in cell and gene therapy.
Preferred Education
- Bachelor’s degree in Life Sciences required.
- PhD, PharmD, or MD strongly preferred.
Preferred Experience/Skills
- 15+ years biopharmaceutical industry experience; at least 8 years Regulatory Affairs.
- Substantial cell and gene therapy experience (CAR-T or T-cell engaging modalities).
- Track record leading major submissions (IND/CTA) and experience preparing BLA/MAA.
- Proven ability to interact and negotiate with regulatory authorities.
- Deep knowledge of FDA ATMP regulations.
- Strategic thinking; strong communication and negotiation; ability to work in complex, matrixed, fast-paced environments.