Sr Manager, Regulatory Affairs Job at Gilead Sciences, Santa Monica, CA

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  • Gilead Sciences
  • Santa Monica, CA

Job Description

Senior Manager of Regulatory Affairs at Kite responsible for developing regulatory strategies, leading submissions to health authorities (FDA, EMA, others), and managing cross-functional teams for oncology drug development programs. Based in California with flexible work policy.

Responsibilities

  • Develop and implement regulatory product strategies for assigned programs
  • Serve as US Regulatory Lead for teams developing regulatory strategies and executing filings
  • Plan, prepare, and review submissions to FDA, EMA, and other authorities for IND, CTA, BLA, MAA
  • Monitor regulatory intelligence and disseminate information affecting development programs
  • Train, manage, and mentor regulatory affairs personnel

Requirements

  • Bachelor's degree with 8+ years regulatory experience, or Master's degree with 6+ years
  • Experience leading regulatory submissions and managing regulatory projects
  • Experience writing or updating regulatory processes
  • Experience working within project teams
  • Advanced degree (MS, PhD, or PharmD) in scientific discipline preferred
  • Knowledge of global regulatory requirements and guidelines
  • Experience preparing/submitting regulatory documents and leading health authority interactions

Compensation: Other US Locations: $143,225–$185,350; Bay Area: $157,590–$203,940

Job Tags

Flexible hours

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