Sr Manager, Regulatory Affairs CMC

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA or El Segundo, CA office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

• Support and drive operational and lifecycle management activities for Regulatory CMC submissions across Kite's global cell therapy / CAR-T clinical and commercial programs.
• Prepare, coordinate, and critically review moderately complex to complex CMC regulatory submissions in accordance with ICH requirements, applicable regional requirements, and internal scientific and procedural standards.
• Contribute to the preparation and submission of CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions supporting cell therapy products.
• Support development and execution of global CMC regulatory strategies aligned with program objectives, business timelines, and evolving health authority expectations for ATMP / CAR-T products.
• Help ensure global harmonization and consistency of Module 3 content across applications, regions, and lifecycle activities.
• Identify CMC risk areas and recommend practical mitigation strategies, alternative approaches, and scenario planning to support complex cell therapy manufacturing and supply strategies.
• Serve as a Regulatory CMC representative on cross-functional project teams, partnering closely with Technical Operations, MSAT, Process & Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders.
• Support regulatory strategy and execution associated with vector-related changes and comparability considerations, as applicable to CAR-T product development and lifecycle management.
• Provide regulatory input for manufacturing site expansion activities, including addition or qualification of new manufacturing sites, updates to registered details, and related post-approval or clinical submission strategies.
• Contribute to inspection readiness activities, including support for regulatory responses and documentation related to site readiness, manufacturing history, inspection history, and pre-approval or routine inspection planning.
• Support preparation of health authority responses (e.g., IRs, RTQs, deficiency responses) and contribute to briefing materials and meeting support for CMC-related agency interactions.
• Assess manufacturing change controls for potential global regulatory impact and provide input on compliant and efficient implementation strategies across regions.
• Support maintenance and accuracy of CMC-specific registered details and associated documentation in relevant systems and…