Director, Regulatory Affairs
About The Position
This role focuses on the development of cutting-edge CAR-T cell therapies in oncology. The Director of Regulatory Affairs/Global Regulatory Lead (GRL) 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. The GRL 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. The company is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness. The company has built a fully integrated capability for discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. The company culture is based on Science, Respect, Collaboration, and Courage.
Requirements
- A minimum of 15+ years in the biopharmaceutical industry, with at least 8 years of direct Regulatory Affairs experience.
- Substantial experience in cell and gene therapy, specifically with CAR-T or T-cell engaging modalities.
- Proven track record of leading major submissions (IND/CTA) and experience in BLA/MAA preparation.
- Proven ability to interact effectively and negotiate with regulatory authorities.
- 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.
Nice To Haves
- Advanced degree (PhD, PharmD, or MD) is strongly preferred.
Responsibilities
- Create and lead comprehensive, creative, and innovative global regulatory strategies to support the development and commercialization of CAR-T cell therapy products.
- Represent the Regulatory Team in cross-functional meetings, ensuring 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.
- Accountable for timely submission and approval of global regulatory dossiers (IND, CTA, BLA, MAA).
- 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.
- Support regional teams in resolving key regulatory issues to expedite clinical study country expansion.
- Partner with CMC, Clinical Development, Translational Medicine, and Medical Affairs teams to align regulatory strategy with scientific breakthroughs and market access goals.
- Review and approve key regulatory documents, including clinical protocols, investigator brochures, and non-clinical reports.
- Provide coaching and mentoring to junior regulatory staff and other RA team members.
- Monitor and analyze emerging regulations, guidelines, and competitor intelligence in the cell and gene therapy field.
Benefits
- Opportunity to earn an annual bonus.
- Eligible to participate in Lyell’s Equity Incentive Plan.
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What This Job Offers
Job Type
Full-time
Career Level
Director
