Overview In this role you will lead Regulatory CMC for Kite's autologous CAR-T programs, shaping global submission strategies and lifecycle management. You will partner with cross-functional teams to align regulatory plans with clinical and commercial objectives, ensuring high-quality module content and proactive risk mitigation. The position offers impact across global markets and evolution of regulatory processes in a fast-paced biotech environment.
Compensation / Benefits- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- comprehensive benefits package
- medical, dental, vision, and life insurance
- flexible working policy with remote work days
Responsibilities- Lead operational and lifecycle management of Regulatory CMC submissions (INDs, IMPDs, BLAs, MAAs, variations, amendments) for global clinical and commercial CAR-T programs
- Act as Regulatory CMC lead on assigned programs, applying advanced global CMC regulatory knowledge for autologous cell therapies
- Author/review/coordinate Module 3 content to ensure harmonization across US, EU, and other authorities
- Develop and execute CMC regulatory strategies aligned with regulatory and business goals, including site additions, process/material/analytical changes, and shelf-life extensions
- Identify CMC regulatory risks, perform scenario planning, and develop mitigation/contingency plans
- Assess regulatory impact of CMC changes through change control processes and define/global strategy
- Support regulatory interactions with health authorities via briefing packages, responses, and meeting preparations for CMC topics
- Collaborate cross-functionally to ensure CMC deliverables meet regulatory, quality, and timeline requirements
- Support continuous improvement and best-practice sharing for regulatory CMC processes in a dynamic environment
Key requirements- Bachelor's degree or Master's degree with corresponding experience
- 5+ years of Regulatory CMC and/or drug development experience
- Experience with FDA-regulated products
- Experience with biologics and/or cell or gene therapy products preferred
- Experience with autologous CAR-T or ATMPs preferred
- Knowledge of global regulatory requirements (FDA, EMA, other international agencies)
- Experience supporting both clinical development and commercial lifecycle management
- Strong written and verbal communication skills; ability to translate CMC topics for diverse stakeholders
- Organized, detail-oriented, able to manage multiple priorities in a fast-paced environment
- Ability to work effectively in cross-functional, matrixed teams
- Self-motivated with accountability and initiative
- Proficiency with MS Word, Excel, PowerPoint, Adobe
- Strong written and verbal communication
- High organization and attention to detail
- Cross-functional collaboration
- Regulatory CMC submissions and lifecycle management
- Module 3 content development and harmonization
- Change control and regulatory risk assessment
