Manager, Regulatory Affairs CMC

Role: Global Regulatory CMC Manager overseeing regulatory chemistry, manufacturing, and controls for Kite’s autologous CAR T-cell therapy portfolio. Primary objectives include leading CMC regulatory submissions, lifecycle management, and change control across clinical and commercial phases internationally. Responsibilities encompass authoring and reviewing Module 3 content, developing global CMC strategies aligned with regulatory requirements, and managing risk and change evaluations. Serving as the key Regulatory CMC representative on cross-functional teams, collaborating with Technical Operations, Quality, Manufacturing, and Regulatory Affairs to ensure compliance and timely deliverables. Requirements: Bachelor’s degree with 6+ years (or Master’s with 4+ years) in a scientific discipline, with extensive experience supporting biologics or cell/gene therapies, especially autologous CAR T products; knowledge of FDA, EMA, and global regulatory standards; proven track record in regulatory submissions and lifecycle management. Preferred skills include strong communication, organization, and cross-functional collaboration, along with self-motivation and adaptability in a fast-paced biotech environment. High-value specifics: focus on cell and gene therapies, global regulatory strategy, lifecycle management, and experience supporting both clinical and commercial stages. Work setup involves hybrid remote and onsite presence in Santa Monica, CA, with planned relocation to nearby offices in 2027.