CMC Regulatory Affairs Manager – Cell Therapy

Kite Pharma, Inc.; Thousand Oaks (CA); Hybrid; USD 133,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Relocation assistance

Job summary

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC in a hybrid role located in California or New Jersey offices. This position supports LVV and cell therapy regulatory activities, with relocation planning to Thousand Oaks or other approved sites.

Expect two days remote and three days onsite, driving strategy and regulatory submissions with cross-functional teams. Qualified candidates have a strong background in CMC, LVV, and product lifecycle management, with 4–6+ years in regulatory

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline.
• Six years' experience with a Bachelor's degree or four years with a Master’s degree.
• Experience with cell and gene therapy/CAR-T/ATMP programs, LVV, regulatory submissions, and health authority interactions.

Responsibilities

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, variations).
• Contribute to Module 3 (CMC) content development for LVV and materials.
• Assist in execution of global CMC regulatory strategies under guidance for cell therapy and LVV.
• Partner with LVV process development, manufacturing, analytical testing, and supply chain teams.
• Support health authority interactions and information requests related to LVV and cell therapy.
• Assess change controls for regulatory impact and lifecycle management.
• Support manufacturing changes, comparability, and site updates for LVV and cell therapy.
• Assist inspection readiness and prepare regulatory documentation.
• Maintain accurate regulatory records in relevant systems.
• Identify regulatory risks and contribute to mitigation strategies.
• Participate in continuous improvement and knowledge-sharing.

Skills

CMC regulatory requirements

Written communication

Organizational skills

Cross-functional collaboration

Regulatory strategy development

Education

Bachelor's degree

Master's degree

Job description

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC in a hybrid role located in California or New Jersey offices. This position supports LVV and cell therapy regulatory activities, with relocation planning to Thousand Oaks or other approved sites.

Expect two days remote and three days onsite, driving strategy and regulatory submissions with cross-functional teams. Qualified candidates have a strong background in CMC, LVV, and product lifecycle management, with 4–6+ years in regulatory