Director of Regulatory Affairs
Lyell Immunopharma
August 21, 2026
On-site
South San Francisco, CA
Corporate Functions
Director of Regulatory Affairs / Global Regulatory Lead (GRL) — CAR-T (Oncology)
Key Role and Responsibilities:
- Develop and execute comprehensive global regulatory strategies for CAR-T cell therapy products.
- Represent Regulatory in cross-functional meetings to ensure alignment with regional regulatory requirements, CMC, and clinical development plans.
- Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the evolving CAR-T regulatory landscape.
- Lead timely submissions and approvals of global regulatory dossiers (IND, CTA, BLA, MAA).
- Act as primary liaison and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and briefing document preparation.
- Support regional teams in resolving key regulatory issues to expedite clinical study country expansion.
- Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs to align regulatory strategy with scientific breakthroughs 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.
- 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:
- 15+ years in biopharmaceutical industry; at least 8 years in Regulatory Affairs.
- Substantial cell/gene therapy experience, specifically CAR-T or T-cell engaging modalities.
- Track record leading major submissions (IND/CTA) and experience with BLA/MAA preparation.
- Proven ability to interact effectively and negotiate with regulatory authorities.
Desired Skills:
- Deep understanding of FDA ATMP regulations.
- Strategic thinking; ability to balance short-term needs with long-term vision.
- Exceptional communication and negotiation skills.
- Ability to work in a complex, matrixed, fast-paced environment.
Benefits/Compensation:
- Salary range: $210,000–$260,000 annually; opportunity for an annual bonus; eligible for Lyell’s Equity Incentive Plan.
Key Role and Responsibilities:
- Develop and execute comprehensive global regulatory strategies for CAR-T cell therapy products.
- Represent Regulatory in cross-functional meetings to ensure alignment with regional regulatory requirements, CMC, and clinical development plans.
- Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the evolving CAR-T regulatory landscape.
- Lead timely submissions and approvals of global regulatory dossiers (IND, CTA, BLA, MAA).
- Act as primary liaison and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and briefing document preparation.
- Support regional teams in resolving key regulatory issues to expedite clinical study country expansion.
- Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs to align regulatory strategy with scientific breakthroughs 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.
- 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:
- 15+ years in biopharmaceutical industry; at least 8 years in Regulatory Affairs.
- Substantial cell/gene therapy experience, specifically CAR-T or T-cell engaging modalities.
- Track record leading major submissions (IND/CTA) and experience with BLA/MAA preparation.
- Proven ability to interact effectively and negotiate with regulatory authorities.
Desired Skills:
- Deep understanding of FDA ATMP regulations.
- Strategic thinking; ability to balance short-term needs with long-term vision.
- Exceptional communication and negotiation skills.
- Ability to work in a complex, matrixed, fast-paced environment.
Benefits/Compensation:
- Salary range: $210,000–$260,000 annually; opportunity for an annual bonus; eligible for Lyell’s Equity Incentive Plan.