Sr Manager, Regulatory Affairs CMC

Senior Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) at Kite, a Gilead company, leading regulatory strategy for CAR T-cell therapies and lentiviral vector manufacturing across early-stage through commercial phases.

Responsibilities

• Lead integrated global CMC regulatory strategies for T-cell drug products and lentiviral vectors
• Develop phase-appropriate control strategies, specifications, and testing requirements
• Assess manufacturing process changes and determine regulatory impact and acceptance criteria
• Guide CMC content for IND submissions, amendments, BLA/MAA filings, and post-approval changes
• Support manufacturing site additions, technology transfers, and process performance qualification

Requirements

• Extensive experience in CMC regulatory strategy for cell or gene therapies
• Deep knowledge of T-cell manufacturing processes and controls
• Expertise in lentiviral vector regulatory pathways and comparability
• Experience with IND, BLA/MAA submissions and health authority engagement
• Strong understanding of process validation, analytical methods, and stability testing
• Leadership experience managing cross-functional regulatory programs
• Proven ability to translate technical decisions into regulatory requirements