Senior Regulatory CMC Manager – Cell Therapy (Hybrid)

Kite Pharma; El Segundo (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Kite Pharma in Santa Monica, CA seeks a Regulatory CMC professional to lead submissions across global cell therapy programs, coordinating content for INDs, CTAs, BLAs and MAAs.

The role emphasizes strong CMC knowledge for ATMP/cell therapies and requires cross-functional leadership to navigate evolving health authority expectations in a fast-moving field.

You will partner with Regulatory, Manufacturing and Quality teams to ensure timely, compliant submissions.

Qualifications

• Strong CMC knowledge for ATMP/cell therapy.
• Experience coordinating regulatory submissions for INDs/CTAs/BLAs/MAAs across global programs.

Responsibilities

• Lead submissions across global cell therapy programs.
• Coordinate content for INDs, CTAs, BLAs, MAAs and post-approval activities.
• Partner with Regulatory, Manufacturing and Quality teams to ensure timely, compliant submissions.

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.