Sr Manager, Regulatory Affairs CMC

Role: Senior Manager, Regulatory Affairs CMC, supporting global regulatory strategies for Kite's cell therapy / CAR-T portfolio across clinical and commercial phases. Responsibilities: oversee end-to-end CMC regulatory activities, prepare and review complex submissions (INDs, BLAs, supplements), support lifecycle management, vector-related changes, manufacturing site expansions, and inspection readiness. Serve as a cross-functional partner on technical teams, providing regulatory input on manufacturing changes, comparability, and site qualification. Requirements: Bachelor's degree with 8+ years (or advanced degree with fewer years) in regulatory affairs, biopharma, or related field; strong understanding of CMC requirements for ATMPs / cell therapies, global regulatory frameworks, and experience supporting clinical and commercial submissions. Preferred: experience with CAR-T, vector-related regulatory considerations, manufacturing site expansion, GMP knowledge, and global change management. HighValue: cell therapy / ATMP / CAR-T, regulatory submissions for clinical and commercial stages, lifecycle management, inspection readiness, cross-functional collaboration. WorkSetup: based in Santa Monica through 2026 with relocation to Thousand Oaks or El Segundo planned for 2027; hybrid working with two remote days.