Associate Director, Global TA Regulatory Liaisons, Virology

1 month ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

Job Title: Associate Director, Global TA Regulatory Liaisons, Virology

Job Summary:

Gilead Sciences is seeking an experienced Associate Director to lead our Global Therapeutic Area (TA) Regulatory Affairs team in Virology. As a key member of our Regulatory Affairs organization, you will be responsible for developing and implementing regulatory strategies for our HIV franchise, ensuring compliance with global regulatory requirements, and collaborating with cross-functional teams to drive business success.

Key Responsibilities:

  • Develop and implement regulatory strategies for our HIV franchise, ensuring compliance with global regulatory requirements.
  • Lead cross-functional teams to drive business success, including Regulatory Submissions Teams and Regulatory Project Teams.
  • Represent Gilead in negotiations with regulatory authorities, including the European Medicines Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
  • Oversee the preparation and maintenance of regulatory submissions, regulatory labeling, and packaging for assigned products or projects.
  • Provide strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.

Requirements:

  • BA/BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment.
  • In-depth understanding of European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
  • Strong interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills.
  • Strong negotiation and conflict resolution skills.

About Gilead Sciences:

Gilead Sciences 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 around the world by advancing the care of patients with life-threatening diseases. Our employees are our greatest asset, and we are proud to offer a work environment that respects individual differences and recognizes each employee as an integral member of our company.

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