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Senior Regulatory Affairs Labeling Director

1 month ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

Job Summary

We are seeking a highly experienced and skilled Senior Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling team at Gilead Sciences International, Ltd. This is a critical role that requires a strong understanding of global labeling regulatory requirements and strategy, as well as excellent leadership and communication skills.

Key Responsibilities

  • Lead the development and implementation of global labeling strategies and policies.
  • Oversee the creation and maintenance of product information and labeling documentation for all Gilead products.
  • Collaborate with cross-functional teams to ensure timely and accurate delivery of product information and labeling updates.
  • Provide strategic input and operational leadership to the Global Regulatory Affairs Labeling team.
  • Represent the GRA Labeling function globally and interact with cross-functional senior leadership to resolve complex issues.

Requirements

  • PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience.
  • Strong experience in prescription drug labeling, including global labeling regulatory requirements and strategy.
  • Excellent leadership and communication skills, with the ability to influence up, down, and across the organization.
  • Proven track record of successes in leading global teams and projects in regulatory or related strategies, programs, projects, and other activities.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a leading biopharmaceutical company that is committed to making a difference in the lives of patients worldwide. We are a diverse and inclusive organization that values innovation, collaboration, and excellence in all that we do.