Director, Regulatory Affairs CMC

We're looking for a Director, Regulatory Affairs CMC to join our team at Kite. The successful candidate will be responsible for providing global regulatory CMC leadership and strategy across the development, lifecycle management, and commercialization of cell therapy and viral vector–based products. This role will involve leading the development, compilation, review, and maintenance of CMC sections for global regulatory submissions, as well as providing expert guidance on global CMC regulatory requirements, change management, and risk mitigation across product lifecycles.

Requirements

• 12 years experience with a BA/BS degree or 10 years of relevant experience with a master's degree. 8 years with a PhD (or equivalent education) in a scientific or related discipline.
• Minimum 10+ years of pharmaceutical/biotechnology industry experience, including 7+ years in Regulatory Affairs CMC.
• Strong experience with cell therapy and/or viral vector–based products; ATMP experience strongly preferred.
• In-depth knowledge of global CMC regulatory requirements across development and post-approval phases.
• Demonstrated expertise in biopharmaceutical development, including drug substance/drug product manufacturing, sterile products, and analytical methods.
• Solid understanding of ICH guidelines, cGMP requirements, and global regulatory expectations.
• Proven experience supporting regulatory inspections and health authority engagements.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans
• Paid time off
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)