Sr Manager, Regulatory Affairs CMC

Senior Manager role supporting regulatory and chemistry, manufacturing, and controls (CMC) activities for Kite's cell therapy and CAR-T programs. The position manages complex submissions across clinical and commercial development, partners with cross-functional teams, and ensures compliant regulatory deliverables throughout the product lifecycle.

Responsibilities

• Support and drive CMC regulatory submissions and lifecycle management for cell therapy and CAR-T clinical and commercial programs
• Prepare, review, and coordinate complex CMC regulatory submissions for INDs, CTAs, BLAs, MAAs, and post-approval submissions
• Develop and execute global CMC regulatory strategies aligned with program objectives and health authority expectations
• Support manufacturing site expansion activities, vector-related changes, and inspection readiness planning
• Partner with cross-functional teams including Technical Operations, Quality, Manufacturing, and Clinical to deliver compliant regulatory deliverables

Requirements

• Strong understanding of CMC regulatory requirements for advanced therapy medicinal products and cell therapy
• Knowledge of ICH requirements and global CMC regulatory frameworks for clinical and commercial products
• Experience authoring or coordinating CMC sections of regulatory submissions and lifecycle management
• Ability to interpret regulatory guidance and apply to product, process, and manufacturing scenarios
• Experience with CAR-T manufacturing, comparability, and site-related regulatory updates preferred
• Risk assessment and cross-functional collaboration skills in fast-paced environments