Director, Regulatory Affairs

Role: Director of Regulatory Affairs/Global Regulatory Lead (GRL) for cutting-edge CAR-T cell therapies in oncology, overseeing global regulatory strategy from early clinical phases through licensure and lifecycle management. Responsibilities: craft and execute innovative regulatory strategies, serve as primary regulatory liaison with agencies (FDA, EMA), lead submissions (IND, BLA, MAA), manage negotiations, and ensure compliance; collaborate cross-functionally with CMC, clinical, translational medicine, and medical affairs teams; review key regulatory documents and mentor junior staff; monitor evolving regulations in cell and gene therapy. Requirements: Bachelor’s in Life Sciences (advanced degrees preferred), 15+ years in biopharma with 8+ in regulatory affairs, extensive experience in cell/gene therapy, proven record of leading major submissions, and agency negotiations; deep knowledge of FDA ATMP regulations. Preferred: strong strategic thinking, exceptional communication, ability to operate in fast-paced, complex environments. High-Value: cell and gene therapy, CAR-T modalities, advanced therapy medicinal products, global regulatory strategy, senior leadership, agency negotiations, lifecycle management. Location: Seattle, WA or South San Francisco, CA; on-site preferred.