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Global Regulatory Affairs Leader

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
Job Title: Executive Director, Regulatory Affairs Labeling

About the Role:

Gilead Sciences International, Ltd. is seeking an experienced Executive Director to lead our Regulatory Affairs Labeling function. As a key member of our Global Regulatory Affairs organization, you will be responsible for creating, updating, and maintaining product information and labeling documentation for all Gilead products across our portfolio.

Key Responsibilities:

  • Lead the Global Regulatory Affairs Labeling function to ensure compliance with evolving global regulatory requirements and support company objectives.
  • Develop and implement global labeling and review processes, metrics, and systems.
  • Oversee the development and management of implementation of global labeling and review processes, metrics, and systems.
  • Represent the GRA Labeling function globally and interact with cross-functional senior leadership to resolve complex issues.
  • Hire, develop, and retain diverse top talent.
  • Ensure the GRA Labeling team prepares timely, high-quality labeling documents in accordance with applicable regulations and the company position.
  • Lead or otherwise oversee Global Safety and Labeling Committee (GSLC) labeling governance discussions.
  • Own and manage the resource plans, performance, and budget for the GRA Labeling function.

Requirements:

  • PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience.
  • Strong experience in prescription drug labeling, including core labeling and regional labeling across U.S., EU, GB, Australia, Canada, Japan, Switzerland, and other markets.
  • Extensive experience leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.
  • Has multiple years' line management (direct reports) experience.
  • Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.
  • Significant experience driving inspection readiness and quality processes across the end-to-end labeling process.
  • Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.
  • Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
  • Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.

About Gilead Sciences International, Ltd.:

Gilead Sciences International, Ltd. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to advancing the treatment of life-threatening diseases and improving the lives of patients worldwide.