Sr Manager, Regulatory Affairs CMC
Gilead
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
Vacancy posted 9 days ago
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