Director, Global Regulatory Affairs, Precision Medicine

7 days ago

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

About the Role

We are seeking a highly skilled and experienced Director, Global Regulatory Affairs, Precision Medicine to join our team at Gilead Sciences International, Ltd. This is a unique opportunity to develop and execute precision medicine regulatory strategies in alignment with our global regulatory strategy.

Key Responsibilities

  • Develop and lead precision medicine regulatory strategies to support Gilead assets from early development through registration.
  • Represent Gilead in key interactions with health authorities and provide regulatory strategy relative to premarket submission, IVD partnering, and regulatory policy.
  • Lead the preparation and filing of HA briefing books and provide inputs on key development documents, clinical protocols, and study reports.
  • Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision medicine.
  • Contribute to local and/or global process improvements which have a significant impact on business.

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.
  • Demonstrated ability to be a fast learner and flexible in a dynamic environment.
  • Advanced knowledge of regulatory requirements, including those related to IVDs, and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
  • Strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills, and proficiencies with Microsoft Office suite.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a global biopharmaceutical company dedicated to delivering innovative therapies to patients with life-threatening diseases. We are committed to making a difference in the lives of patients and their families.

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