Sr Manager, Regulatory Affairs

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. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

This role may also be located at our Foster City and or Parsippany location with a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite.

Responsibilities (include but are not limited to):

• 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 the 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, and mentor other regulatory affairs personnel

• Work externally to engage in regulatory policy initiatives

• Other duties as assigned

Basic Requirements:

• BA/BS with 8+ years' relevant experience.

OR

• MA/MS/MBA with 6+ years' relevant experience.

• Experience leading regulatory submissions and other regulatory projects is strongly preferred.

• Experience writing or updating processes.

• Experience working in project teams.

• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is preferred.

Preferred Qualifications:

• MS, PhD or PharmD in a scientific discipline preferred

• Knowledge and understanding of global regulations and guidelines

• Previous experience in the preparation and submission of regulatory documents

• Previous experience in attending and leading a team to prepare for major health authority interactions is highly desirable (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)

• Experience with investigational drugs, including late stage development, and marketed products desired

• Ability to work in a cross-functional team environment with experience managing people and project teams

• Strong attention to detail and the ability to…