Sr Manager, Regulatory Affairs

Gilead Sciences•Foster City, CA

1d•$143,225 - $203,940•Hybrid

About The Position

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.

Requirements

BA/BS with 8+ years’ relevant experience.
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.

Nice To Haves

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 prioritize multiple tasks
Excellent organizational, computer and documentation skills and an ability to prioritize effectively
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment

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 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