Senior Director, CMC Regulatory Affairs

Role: Senior Director, CMC Regulatory Affairs responsible for leading regulatory strategies for cell therapy products under development. Core responsibilities include providing strategic CMC regulatory leadership for multiple Allogeneic CAR T programs, managing global regulatory submissions (INDs, CTAs, BLAs, MAAs), and serving as the primary regulatory liaison with authorities (FDA, EMA, Japan). The role involves negotiating with agencies, ensuring compliance with regulations (GMP, ICH), overseeing submission quality, supporting quality systems (change control, inspections), and managing regulatory documentation throughout product lifecycle. Qualifications: advanced scientific degree or equivalent, extensive CMC regulatory experience in biotech/pharma, knowledge of biologics development regulations, and familiarity with submission elements like eCTD. Preferred skills include experience with orphan drugs, BTD, RMAT designations, and supervisory experience. High-value specifics: focus on cell therapy (CAR T), early to late development stages, global regulatory interactions, and lifecycle management. Work setup: hybrid in South San Francisco, with up to 2 remote days; requires ability to handle multiple projects in a fast-paced environment.