Manager, Regulatory Affairs CMC

Manager, Regulatory Affairs CMC at Kite (Gilead Sciences) leads chemistry, manufacturing, and controls regulatory submissions for autologous CAR T-cell therapies in clinical development and commercial expansion. The role manages global CMC lifecycle, regulatory strategy, and cross-functional collaboration across technical operations, quality, and manufacturing teams.

Responsibilities

• Lead operational and lifecycle management of regulatory CMC submissions (INDs, IMPDs, BLAs, MAAs, variations, amendments) for global CAR-T programs
• Author, review, and coordinate Module 3 content ensuring global alignment across US, EU, and international health authorities
• Develop and execute CMC regulatory strategies supporting process changes, raw material updates, analytical improvements, and shelf-life extensions
• Serve as Regulatory CMC lead on assigned program and platform teams, applying advanced knowledge of autologous cell therapy requirements
• Identify CMC regulatory risks, anticipate regulator questions, and develop mitigation plans through change control processes

Requirements

• Bachelor's degree and six years' experience, or Master's degree and four years' experience
• Scientific degree preferred (Chemistry, Biochemistry, Biology, Chemical Engineering, or related field)
• 5+ years regulatory CMC and/or drug development experience with FDA-regulated products
• Experience with biologics, cell therapy, or gene therapy products strongly preferred
• Knowledge of global regulatory requirements (FDA, EMA, international agencies)
• Strong written and verbal communication skills with ability to translate complex CMC topics
• Experience supporting both clinical development and commercial lifecycle management

Compensation: $133,195.00 - $172,370.00