New · posted Oct 15
Lyell Immunopharma · Biotechnology
Director, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
This role can be remote with regular travel to either our Seattle, WA or South San Francisco, CA offices.
The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be focusing on the development of cutting-edge CAR-T cell therapies in oncology.
As the GRL, you will define, develop, and execute the global regulatory strategy for assigned CAR-T programs from early clinical development through licensure (BLA/MAA) and lifecycle management. You will serve as the primary regulatory representative to global health authorities (FDA, EMA, etc.), ensuring alignment with business objectives and driving innovative approaches to accelerate the development of transformative therapies for patients.
What you need
PREFERRED EDUCATIONnice to have
Bachelor’s degree in Life Sciences required. Advanced degree (PhD, PharmD, or MD) is strongly preferred.
PREFERRED EXPERIENCEnice to have
Experience: A minimum of 15+ years in the biopharmaceutical industry, with at least 8 years of direct Regulatory Affairs experience.
Modalities: Substantial experience in cell and gene therapy, specifically with CAR-T or T-cell engaging modalities.
Submissions: Proven track record of leading major submissions (IND/CTA) and experience in BLA/MAA preparation.
HA Interactions: Proven ability to interact effectively and negotiate with regulatory authorities.
Desired Skillsnice to have
- Deep understanding of FDA regulations for Advanced Therapy Medicinal Products (ATMPs).
- Strong strategic thinking and ability to balance short-term needs with long-term vision.
- Exceptional communication and negotiation skills.
- Proven ability to work in a complex, matrixed, and fast-paced environment
What you'll do
Global Regulatory Strategy & Leadership
- Develop & Execute Strategy: Create and lead comprehensive, creative, and innovative global regulatory strategies to support the development and commercialization of CAR-T cell therapy products.
- Represent Regulatory: Represent the Regulatory Team in cross-functional meetings, ensuring alignment with regional regulatory requirements, CMC, and clinical development plans.
- Risk Mitigation: Proactively identify regulatory risks, develop contingency plans, and anticipate hurdles in the evolving CAR-T regulatory landscape.
- Drive Milestones: Accountable for timely submission and approval of global regulatory dossiers (IND, CTA, BLA, MAA).
Health Authority Interactions
- Primary Liaison: Act as the primary point of contact and lead negotiations with regulatory agencies (FDA, EMA, etc.), including managing FDA meetings (Pre-IND, EOP2, Pre-BLA) and briefing document preparation.
- Agency Negotiation: Support regional teams in resolving key regulatory issues to expedite clinical study country expansion.
Cross-Functional Collaboration
- Strategic Input: Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs teams to align regulatory strategy with scientific breakthroughs and market access goals.
- Content Review: Review and approve key regulatory documents, including clinical protocols, investigator brochures, and non-clinical reports.
- Mentor Staff: Provide coaching and mentoring to junior regulatory staff and other RA team members.
Regulatory Intelligence
- Stay Current: Monitor and analyze emerging regulations, guidelines, and competitor intelligence in the cell and gene therapy field.
Pay and benefits
$210,000 – $260,000 a year
Employer providedThe salary range for this position is $210,000 to $260,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
Annual bonus
Equity Incentive Plan
Equal opportunity, accessibility and legal noticesLyell Immunopharma's statements, word for word
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $210,000 | — | $260,000 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Lyell Immunopharma's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Lyell Immunopharma's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions6
- Documentation and SOPs3
- GMP and compliance2
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
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Director, Regulatory Affairs at Lyell Immunopharma
Open until filled. $210K–$260K a year, employer provided.