Manager, Regulatory Affairs CMC
$133.2k - $172.37kGilead
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
Vacancy posted 5 days ago
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