Associate Director, Global TA Regulatory Liaisons, Virology

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences Full time

Job Description

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer, working relentlessly to develop therapies that improve lives and ensure access to these therapies across the globe.

We are seeking a highly skilled and experienced Associate Director, Global TA Regulatory Liaisons, Virology to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in the discovery and development of life-changing scientific innovations.

Key Responsibilities:

  • Develop and implement regulatory strategies for multiple Gilead products or projects.
  • Represent Gilead in negotiations with regulatory authorities.
  • Lead Regulatory Submissions Teams or other Regulatory Project Teams.
  • Oversee 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 an equal opportunity employer committed to a diverse workforce. We are proud to be a company that values individual differences and recognizes each employee as an integral member of our team. Our workforce reflects these values and celebrates the individuals who make up our growing team.

We provide a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.



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