Executive Director, Regulatory Affairs and Labeling

2 months ago


Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full time
Job Summary

Gilead Sciences International, Ltd. is seeking a highly experienced and skilled Executive Director to lead the Global Regulatory Affairs and Labeling function. This is a critical role that requires a strong understanding of regulatory requirements and a proven track record of leading cross-functional teams.

Key Responsibilities
  • Lead the development and implementation of global regulatory strategies and labeling 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 and Labeling organization.
  • Represent the function during internal and external audits and inspections.
  • Lead and manage a team of labeling strategists, operations, and compliance specialists.
  • Develop and manage the resource plans, performance, and budget for the Global Regulatory Affairs and Labeling function.
  • Drive digital innovation across the global labeling value chain.
Requirements
  • PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience.
  • Strong experience in prescription drug labeling and regulatory affairs.
  • Extensive experience leading development of regulatory labeling or related strategies.
  • Experience working with cross-functional teams and regulatory authorities.
  • Strong leadership and management skills.
  • Ability to influence up, down, and across the organization.
  • Exceptional interpersonal and communication skills.
  • Ability to travel when needed.
What We Offer

Gilead Sciences International, Ltd. offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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