Senior Regulatory CMC Manager – Cell Therapy (Hybrid)

Kite Pharma; El Segundo (CA); Hybrid; USD 143,000 - 185,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Medical/dental/vision insurance

Job summary

Kite Pharma in Santa Monica, CA is seeking a Regulatory CMC professional to drive submissions across global cell therapy programs. You will coordinate content for INDs, CTAs, BLAs, MAAs, and post-approval activities, partnering with Regulatory, Manufacturing and Quality teams.

The role requires strong CMC knowledge for ATMP/cell therapy, cross-functional leadership, and the ability to navigate evolving health authority expectations.

Qualifications

• Strong understanding of CMC regulatory requirements for ATMPs / cell therapy products.
• Experience authoring or coordinating CMC sections of regulatory submissions.
• Ability to interpret regulatory guidance and apply it to product manufacturing scenarios.

Responsibilities

• Support and drive regulatory CMC submissions for global programs.
• Prepare, coordinate, and review CMC submissions per ICH and regional requirements.
• Contribute to CMC content for INDs, CTAs, BLAs, MAAs and post-approval submissions.

Skills

CMC regulatory affairs

ICH guidance

Regulatory submissions

CAR-T / ATMP knowledge

cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Master's degree or PhD

Job description

Kite Pharma in Santa Monica, CA is seeking a Regulatory CMC professional to drive submissions across global cell therapy programs. You will coordinate content for INDs, CTAs, BLAs, MAAs, and post-approval activities, partnering with Regulatory, Manufacturing and Quality teams.

The role requires strong CMC knowledge for ATMP/cell therapy, cross-functional leadership, and the ability to navigate evolving health authority expectations.