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Head of Regulatory Affairs Operations

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Head of Business Operational Excellence M/F

Description

POSITION OVERVIEW:

Gilead Sciences, Inc. is seeking a highly skilled and experienced professional to lead our Business Operational Excellence function. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing processes and frameworks to drive excellence in our day-to-day operations.

Responsibilities:

  • Lead the development and implementation of process improvements and frameworks to drive excellence in Global Regulatory Affairs.
  • Collaborate with cross-functional teams to identify and prioritize business drivers and develop strategies to address them.
  • Develop and manage budgets and resource plans to support the Business Operational Excellence function.
  • Ensure compliance with established practices, policies, and processes, and regulatory requirements.
  • Lead the incubation period for new process and departmental initiatives and appropriate RA capabilities.
  • Develop and implement training programs to support the development of the Business Operational Excellence team.
  • Proactively identify regulatory or related risks/issues and develop mitigation and decision-making forums.
  • Collaborate with the Head of Vendor Governance and Management Regulatory Affairs to coordinate provision of performance metrics on vendor use.

Requirements:

We are seeking a highly skilled and experienced professional with a strong track record of leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities. The ideal candidate will have:

  • 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.
  • Multiple years' line management experience and 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.
  • Expert knowledge of the drug development process, global and regional regulatory requirements, and other business functions.
  • 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.

Equal Employment Opportunity (EEO)

Gilead Sciences, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.