Head of 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 role will be responsible for overseeing the development and implementation of global labeling strategies, ensuring compliance with regulatory requirements, and driving innovation in labeling operations.

Key Responsibilities
  • Lead the Global Regulatory Affairs and Labeling function, ensuring compliance with evolving global regulatory requirements and supporting company objectives.
  • Develop and implement global labeling strategies, working closely with cross-functional teams to ensure timely and effective delivery of product information and labeling updates.
  • Oversee the development and management of global labeling and review processes, metrics, and systems, ensuring alignment with regulatory requirements and company policies.
  • Represent the Global Regulatory Affairs and Labeling function globally, interacting with cross-functional senior leadership to resolve complex issues and provide expertise in global labeling best practices.
  • Lead and manage a team of labeling strategists, operations, and compliance specialists, providing guidance and oversight to ensure effective and efficient global processes.
  • Drive digital innovation across the global labeling value chain, leveraging technology to improve efficiency and effectiveness.
  • Develop and manage the resource plans, performance, and budget for the Global Regulatory Affairs and Labeling function.
Requirements
  • PharmD/PhD/MA/MS/MBA/BA/BS with significant relevant experience in prescription drug labeling and regulatory affairs.
  • Strong experience in global labeling regulatory requirements and strategy, including industry best practices and standards.
  • Expert-level knowledge in labeling operations compliance, including quality management processes and systems.
  • Proven track record of leading organizations and teams to achieve short- and long-range strategies, plans, and objectives.
  • Ability to influence up, down, and across the organization and externally in a collaborative manner.
  • Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.
  • Exceptional interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills, with ability to distill complex matters into a clear business case and roadmap for execution.

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