Sr Manager, Regulatory Affairs CMC

Role: Senior Regulatory CMC leader supporting cell therapy and viral vector programs at Kite, focusing on global strategy development across early, pivotal, and post-approval stages. Responsibilities: oversee integrated CMC regulatory strategies for T-cell drug products and lentiviral vectors, ensuring compliance and alignment with program goals; serve as the regulatory representative on technical teams; guide manufacturing process changes, control strategies, and lifecycle management; prepare and review submission content for INDs, BLAs, MAAs, and regulatory responses; lead regulatory discussions with health authorities; and contribute to cross-functional collaboration and team leadership. Requirements: Bachelor's degree plus 8+ years or Master's/PhD with relevant experience in biotechnology, pharmaceutical sciences, or chemistry; extensive regulatory affairs expertise in cell therapies and viral vectors; technical knowledge of autologous T-cell manufacturing and lentiviral vector production; experience supporting global submissions, process validation, comparability studies, and lifecycle management; strong strategic, communication, and leadership skills. HighValue: focus on CAR T-cell therapies, gene editing, early to late-stage development, global regulatory interactions, and manufacturing process oversight. WorkSetup: hybrid in Santa Monica, CA, with planned relocation to CA offices in 2027; support for flexible work arrangements.