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.Job DescriptionManager, Regulatory Affairs CMC Company OverviewWe’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.Job DescriptionWe are seeking a motivated Regulatory Affairs CMC Manager to support our cell therapy portfolio across clinical and commercial programs. The role will focus on Europe and Rest of World (RoW) countries and will act as the Regulatory Affairs CMC Lead for the preparation, coordination, and execution of regulatory submissions.This position requires strong regulatory CMC expertise, the ability to lead in a matrix environment, and close collaboration with cross‑functional stakeholders to ensure high‑quality, compliant, and timely regulatory deliverables.Job ResponsibilitiesAct as the Regulatory Affairs CMC Lead for assigned clinical and commercial cell therapy programs, ensuring high‑quality and timely regulatory CMC deliverables.Contribute to the development and execution of CMC regulatory strategies, aligned with product development stage, regional requirements, and overall program objectives.Author, review, and critically assess regulatory CMC documentation, ensuring accuracy, consistency, and compliance.Provide regulatory CMC guidance and input to cross‑functional teams to support product development, lifecycle management, and commercialization activities.Interpret and apply EMA, EU, Ph. Eur., and relevant RoW regulatory requirements, with a strong understanding of ATMP‑specific expectations and practical implementation.Support alignment of cross‑functional perspectives into a consistent regulatory CMC position, balancing compliance, timelines, and operational feasibility.Assess and evaluate proposed CMC change controls to determine their regulatory impact across clinical and commercial programs.Ensure intern...