Manager, Regulatory Affairs CMC
About The Position
The Manager, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory submissions, lifecycle management, and change management in alignment with global regulatory strategy and business objectives. The individual will serve as a key Regulatory CMC representative on cross functional program teams, partnering closely with Technical Operations, Quality, Process Development, Analytical, Manufacturing, and Global Regulatory Affairs. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, Foster City, CA or El Segundo, CA office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.
Requirements
- Bachelor’s degree and Six Years' experience OR Master's degree and Four Years' experience
- Strong written and verbal communication skills, with the ability to translate complex CMC topics for diverse stakeholders
- Highly organized, detail‑oriented, and comfortable managing multiple priorities in a fast‑paced environment
- Demonstrated ability to operate effectively in cross‑functional, matrixed teams
- Self‑motivated with a strong sense of ownership, accountability, and follow‑through
- Ability to adapt quickly to evolving regulatory landscapes and business needs
- High degree of professionalism, integrity, and ethical conduct
- Proficiency with standard business software tools (e.g., MS Word, Excel, PowerPoint, Adobe)
Nice To Haves
- A degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field)
- 5+ years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA‑regulated products
- Experience supporting biologics and/or cell or gene therapy products is strongly preferred
- Experience with autologous CAR‑T cell therapy or advanced therapy medicinal products (ATMPs)
- Working knowledge of global regulatory requirements (FDA, EMA, and other international agencies)
- Experience supporting both clinical development and commercial lifecycle management
Responsibilities
- Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting global clinical and commercial CAR‑T programs
- Serve as the Regulatory CMC lead on assigned program and/or platform teams, applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies
- Author, review, and coordinate Module 3 (M3) content, ensuring global alignment and harmonization across regions (US, EU, and other international health authorities)
- Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies, including support for global site additions, process changes, raw material changes, analytical updates, and shelf‑life extensions
- Proactively identify CMC regulatory risks and lead scenario planning, including anticipation of regulator questions and development of mitigation and contingency plans
- Assess and provide regulatory impact evaluations for CMC changes through formal change control processes, ensuring appropriate global regulatory strategies are defined and executed
- Support interactions with global health authorities by contributing to briefing packages, written responses, and regulatory meeting preparations specific to CMC topics
- Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
- Support continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Manager
