Sr Manager, Regulatory Affairs CMC

Role: Regulatory CMC Lead supporting cell therapy and viral vector programs at Kite, focusing on global regulatory strategies across early to late development stages, including registration and post-market phases. Responsibilities: develop and execute integrated CMC strategies for T-cell drug products and lentiviral vectors, serve as the primary regulatory liaison, guide manufacturing process changes, and prepare regulatory submissions such as INDs, BLAs, and MAAs. Ensure process and analytical validation, comparability, and lifecycle management align with global requirements; lead responses to health authority inquiries and manage post-approval changes. Requirements: Bachelor's degree with 8+ years (or advanced degrees with proportionate experience) in life sciences, biotech, or related fields; extensive experience supporting cell and gene therapy CMC development, including manufacturing, analytical methods, and global regulatory submissions; hands-on knowledge of GMP, ICH, and regional regulations. Preferred: direct experience with autologous T-cell manufacturing, lentiviral vector production, and cross-functional team leadership. HighValue: focus on cell and gene therapies for cancer, regulatory strategy development, process validation, and lifecycle management of advanced therapy medicinal products. WorkSetup: hybrid (remote/onsite) in California with planned relocation to Thousand Oaks, Foster City, or El Segundo in 2027; some travel may be required.