Sr Manager, Regulatory Affairs CMC
Gilead
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
Vacancy posted 3 days ago
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