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Gilead Sciences
Gilead Sciences
H1B Visa SponsorBiotechnologyConsultingHealthcare
Gilead Sciences is a biopharmaceutical company developing and delivering medicines for life-threatening diseases. Its work has a strong focus on virology, including HIV and hepatitis, alongside growing research in oncology and inflammation. The company supports a global portfolio of more than 25 products and 50 clinical programs, while also investing in HIV research and health-equity initiatives. For job seekers, Gilead Sciences offers opportunities to contribute to research, development, and healthcare programs aimed at improving patient outcomes worldwide.
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Senior Manager, Regulatory Affairs — Santa Monica Hybrid

Lead regulatory strategy and submissions for Kite’s CAR T-cell cancer immunotherapies. Guide FDA, EMA, and global health-authority interactions while coordinating regulatory project teams.

USUnited StatesCACalifornia
$157,590 – $203,940 / year
HybridFull-timeSeniorEnglish RequiredCompliance

Description

  • Create and execute regulatory strategies for assigned products.
  • Represent regulatory affairs on cross-functional development teams.
  • Provide regulatory direction, including assessment of risks, mitigations, and contingency plans.
  • Plan, prepare, and review clinical-trial and marketing submissions to the FDA, EMA, and other national authorities, including IND, CTA, BLA, and MAA filings.
  • Lead assigned project activities and maintain compliance with applicable FDA requirements.
  • Oversee regulatory aspects of products and projects, including schedules and deliverables.
  • Ensure regulatory documents are accurate, complete, verifiable, and compliant.
  • Act as the US Regulatory Lead for designated Regulatory Project Teams.
  • Track, evaluate, and share regulatory intelligence affecting development programs.
  • Interpret regulations, directives, and guidance and provide practical advice.
  • Prepare meeting requests and briefing materials, coordinate health-authority meeting teams, and serve as the primary contact for routine interactions.
  • Coordinate responses to requests for information from regulatory authorities.
  • Train, supervise, and mentor regulatory affairs staff.
  • Participate in external regulatory policy initiatives.
  • Complete additional duties as assigned.

Requirements

  • BA or BS with at least 8 years of relevant experience, or MA, MS, or MBA with at least 6 years of relevant experience.
  • Regulatory submission leadership and regulatory project management experience are strongly preferred.
  • Experience creating or updating processes.
  • Experience working within project teams.
  • Experience across one or more Gilead therapeutic areas and multiple stages of drug development is preferred.
  • Knowledge of global regulations and regulatory guidelines.
  • Prior experience preparing and submitting regulatory documents.
  • Experience participating in and leading team preparation for major health-authority interactions is highly desirable.
  • Experience with investigational drugs, including late-stage development, and marketed products is desired.
  • Ability to work cross-functionally and manage people and project teams.
  • Strong attention to detail with the ability to prioritize multiple tasks.
  • Excellent organizational, computer, and documentation skills.
  • Strong verbal and written communication and interpersonal skills.
  • An MS, PhD, or PharmD in a scientific discipline is preferred.

Benefits

  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives.
  • Paid time off.
  • Company-sponsored medical insurance.
  • Company-sponsored dental insurance.
  • Company-sponsored vision insurance.
  • Company-sponsored life insurance.
  • Flexible working policy with two remote days and three onsite days each week.

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