Senior Manager, CMC Regulatory Affairs – Hybrid (CAR-T)

Kite Pharma, Inc.; Santa Monica (CA); Hybrid; USD 143,000 - 185,000; Full time

Job summary

Kite Pharma, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to drive complex CMC regulatory activities for its cell therapy portfolio.

The role partners with Technical Operations, Quality, Manufacturing, and Clinical teams to ensure timely, compliant submissions and lifecycle management across global programs. Hybrid work arrangements are available with relocation to Thousand Oaks, El Segundo, or ongoing Santa Monica posting through 2026, and a planned move in 2027.

Qualifications

• Bachelor's degree in life sciences or related field; eight years RA-CMC experience.
• Experience coordinating CMC submissions across clinical and commercial programs.
• Knowledge of ICH, global CMC requirements and regulatory guidance.

Responsibilities

• Lead and drive CMC regulatory submissions and lifecycle activities.
• Coordinate with cross-functional teams on regulatory strategy and timelines.
• Support regulatory responses, inspections, and site expansion activities.
• Contribute to regulatory strategy for ATMP/CAR-T programs and site readiness.

Skills

CMC regulatory knowledge

Cross-functional collaboration

Regulatory submissions

IND/CTA/BLA submissions

ATMP / CAR-T familiarity

Risk assessment & mitigation

Lifecycle management

Regulatory strategy

Education

Bachelor's Degree in life sciences

Master's Degree

PhD

Job description

Kite Pharma, Inc. is seeking a Senior Manager, Regulatory Affairs CMC to drive complex CMC regulatory activities for its cell therapy portfolio.

The role partners with Technical Operations, Quality, Manufacturing, and Clinical teams to ensure timely, compliant submissions and lifecycle management across global programs. Hybrid work arrangements are available with relocation to Thousand Oaks, El Segundo, or ongoing Santa Monica posting through 2026, and a planned move in 2027.