Director, Global Regulatory Affairs, Precision Medicine

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

About the Role

We are seeking a highly skilled Regulatory Affairs Director to join our team at Gilead Sciences International, Ltd. as a Director, Global Regulatory Affairs, Precision Medicine. This is a unique opportunity to develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross-functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.

Key Responsibilities

  • Develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy.
  • Collaborate with cross-functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations.
  • Work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
  • Provide regulatory strategy and support, ensuring communication of a clear vision for the translational discovery, development, and validation of biomarkers in clinical studies.
  • Provide operational and technical regulatory assistance through all stages of clinical development through global registration for IVD projects.
  • Identify predictive biomarkers that may influence drug product's clinical development strategy and proof of mechanism.

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.
  • Experience in in vitro diagnostic development strongly preferred.
  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Demonstrates advanced knowledge of regulatory requirements (including those related to IVDs, notably IVDR) and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
  • In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
  • Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
  • Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
  • Ability to lead and influence programs, projects and/or initiatives.
  • Strong interpersonal and communication skills with ability to rapidly understand and navigate team dynamics.
  • Proven ability to work successfully in a team-oriented, matrixed environment.
  • When needed, ability to travel.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. We are committed to advancing the science of medicine and improving the lives of people around the world.

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