Sr Manager, Regulatory Affairs

About the role

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.

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission! Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our El Segundo/Thousand Oaks office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. This role may also be located at our Foster City and/or Parsippany location.

Responsibilities

• Develop and implement regulatory product strategies
• Represent the regulatory function on cross-functional development teams
• Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies
• Plan, prepare, and review submissions to required authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
• Lead and oversee activities for assigned projects in line with FDA applicable requirements to ensure compliance
• Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
• Serve as the US Regulatory Lead (USRL) for assigned Regulatory Project Teams in the development of regulatory strategies and advise in the development of applicable strategies and execution of filings
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Provide interpretation of and advice regarding regulations, directives, and guidance
• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and work with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
• Coordinate and prepare responses to requests for information from regulatory authorities
• Train, manage,