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Global Regulatory Affairs Business Operations Director

2 months ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Global Regulatory Affairs Business Operations Director

Job Summary:

We are seeking a highly experienced and skilled Global Regulatory Affairs Business Operations Director to join our team at Gilead Sciences, Inc. This role will be responsible for leading the development and implementation of global regulatory affairs business operations strategies, processes, and systems to ensure compliance and excellence in regulatory affairs.

Key Responsibilities:

  • Lead the development and implementation of global regulatory affairs business operations strategies, processes, and systems.
  • Collaborate with cross-functional teams to ensure compliance and excellence in regulatory affairs.
  • Develop and manage budgets and resource plans for assigned areas.
  • Ensure suitable processes are in place for global regulatory affairs to function efficiently and in compliance.
  • Collaborate with the Head of Vendor Governance and Management Regulatory Affairs to coordinate provision of performance metrics on vendor use.

Requirements:

  • Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities.
  • Experience working as a Global or Regional Regulatory Lead within one or more Gilead therapeutic areas and at varying stages of drug development is strongly preferred.
  • Multiple years' line management (direct reports) experience.
  • Proven abilities to independently lead a diverse global team.
  • Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.

Knowledge & Other Requirements:

  • Expert knowledge of the drug development process, global and regional regulatory requirements, and other business functions.
  • Organizational design and transformation leadership experience.
  • Proven 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.

About Gilead Sciences, Inc.:

Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to making a difference in the lives of people affected by serious and complex diseases.