Manager, Regulatory Affairs CMC
Kite Pharma
Summary
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.
Job description
Key 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
Basic Qualifications
Bachelor's degree and Six Years' experience OR Master's degree and Four Years' experience
Preferred Qualifications
- 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
Skills and Competencies
- 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)
Work Environment
Fast-paced, collaborative biotechnology environment. Requires flexibility, adaptability, and a proactive, solution-oriented mindset. Minimal day-to-day supervision with high expectations for independent judgment and initiative.
Requirements
- Bachelor's degree and Six Years' experience OR Master's degree and Four Years' experience
- 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
- 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)
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.