Sr Manager, Regulatory Affairs
Gilead Sciences
Summary
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.
Job description
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
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 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
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.
- 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
Benefits
- Medical, Dental & Vision
- Life Insurance
- Paid Time Off
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.