Manager, Regulatory Affairs CMC

Role: The Manager, Global Regulatory CMC, oversees regulatory chemistry, manufacturing, and controls (CMC) activities for Kite’s autologous CAR T-cell therapy portfolio, supporting global clinical development and commercial expansion. Responsibilities include managing CMC submissions (INDs, BLAs, variations), developing regulatory strategies, authoring and reviewing Module 3 content, and coordinating lifecycle management and change controls across regions. The role also involves risk assessment, regulatory interaction support, and cross-functional collaboration with Technical Operations, Quality, and Manufacturing teams. Requirements: Bachelor’s degree plus 6 years or Master’s degree plus 4 years of relevant experience; strong knowledge of global CMC regulatory requirements, particularly for biologics, cell, or gene therapies; experience with FDA-regulated products and lifecycle management; excellent communication skills. Preferred: 5+ years in regulatory CMC or drug development, experience in cell or gene therapy, and understanding of international agencies (FDA, EMA). High-value specifics include biologics, cell/gene therapy, autologous CAR T therapies, global regulatory strategy, and involvement in clinical and commercial phases. The position is based in Santa Monica, CA, with a hybrid work model and planned relocation to nearby offices in 2027.