Hybrid Manager, CMC Regulatory Affairs – Cell Therapy & LVV

Kite Pharma, Inc.; San Francisco (CA); Hybrid; USD 133,000 - 172,000; Full time

Job summary

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to guide CMC regulatory activities for LVV and cell therapy programs.

The role involves global submissions, lifecycle management, and cross-functional collaboration across Process Design, MSAT, Quality, Manufacturing, and Supply Chain. The position requires strong knowledge of CMC regulatory requirements, ICH guidelines, and experience with regulatory submissions, health authority interactions, and LVV manufacturing processes.

Qualifications

• Bachelor’s degree with Six Years' experience
• Master’s degree with Fours Years' experience
• Experience with cell and gene therapy / CAR-T / ATMP programs, including LVV, viral vector manufacturing, characterization, control strategies, and lifecycle management
• Experience supporting regulatory submissions and health authority interactions
• Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization
• Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management

Responsibilities

• Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations).
• Contribute to Module 3 (CMC) content development aligning with global regulatory requirements for cell therapy products and LVV.
• Assist in execution of global CMC regulatory strategies under guidance of senior staff for cell therapy products and LVV manufacturing platforms.
• Partner with cross-functional teams to support regulatory deliverables.
• Support health authority interactions, including responses to information requests and meeting materials related to LVV manufacturing processes, control strategy, potency, safety testing, and process validation.
• Assess change controls for regulatory impact and support lifecycle management including LVV manufacturing processes, raw materials, analytical methods, sites, and production scale.

Job description

Kite Pharma, Inc. is seeking a Manager, Regulatory Affairs CMC to guide CMC regulatory activities for LVV and cell therapy programs.

The role involves global submissions, lifecycle management, and cross-functional collaboration across Process Design, MSAT, Quality, Manufacturing, and Supply Chain. The position requires strong knowledge of CMC regulatory requirements, ICH guidelines, and experience with regulatory submissions, health authority interactions, and LVV manufacturing processes.