CMC Regulatory Lead, Cell Therapy – Hybrid

Kite Pharma; Thousand Oaks (CA); Hybrid; USD 143,000 - 185,000; Full time

Job summary

Kite Pharma, a leader in CAR-T cell therapies, is seeking a Senior Manager, Regulatory Affairs CMC to drive complex regulatory activities across clinical and commercial programs. This role partners with Manufacturing, Quality, MSAT, Clinical, and Regulatory teams to shape global strategies, prepare CMC submissions, and ensure timely, compliant deliverables throughout the product lifecycle.

Relocation to Thousand Oaks, CA is planned beginning in January 2027, with a flexible policy offering two

Qualifications

• Bachelor's degree with extensive experience in Regulatory CMC for ATMPs or cell therapy.
• Experience authoring or coordinating CMC submissions and lifecycle management.
• Strong understanding of ICH requirements and global trends in CMC regulatory affairs.
• Ability to interpret regulatory guidance and apply to product and manufacturing scenarios.
• Experience with CAR-T/manufacturing changes is preferred.

Responsibilities

• Support and drive operational and lifecycle management activities for regulatory CMC submissions.
• Prepare and review complex CMC submissions per ICH and regional requirements.
• Contribute to CMC content for INDs, CTAs, BLAs, MAAs, and post-approval submissions.
• Develop global CMC regulatory strategies aligned with program objectives and timelines.
• Collaborate with cross-functional teams including Manufacturing, Quality, and Clinical.
• Assist in inspection readiness activities and regulatory responses.
• Provide regulatory input for site expansion and post-approval strategies.

Skills

CMC regulatory knowledge

CAR-T regulatory knowledge

Regulatory strategy development

Regulatory submissions coordination

Cross-functional collaboration

Project management

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in related field

Job description

Kite Pharma, a leader in CAR-T cell therapies, is seeking a Senior Manager, Regulatory Affairs CMC to drive complex regulatory activities across clinical and commercial programs. This role partners with Manufacturing, Quality, MSAT, Clinical, and Regulatory teams to shape global strategies, prepare CMC submissions, and ensure timely, compliant deliverables throughout the product lifecycle.

Relocation to Thousand Oaks, CA is planned beginning in January 2027, with a flexible policy offering two