Sr Manager, Regulatory Affairs CMC

Gilead Sciences · Santa Monica, CA +2 more

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RegulatoryFull-time$143k–$185kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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