Director, Global Regulatory Affairs, Precision Medicine Specialist

2 months ago

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

About the Role

Gilead Sciences International, Ltd. is seeking a highly skilled and experienced Director, Global Regulatory Affairs, Precision Medicine to join our team. As a key member of our regulatory affairs department, you will play a critical role in developing and executing 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's regulatory affairs expertise on cross-functional teams and present to senior leadership as required.
  • Maintain current understanding of global IVD/CDx regulations and assess their impact on drug and IVD/CDx development and registration activities.
  • Provide regulatory input during clinical development to ensure compliance with global and local regulatory requirements.
  • Lead the preparation and filing of HA briefing books and provide inputs on key development documents.
  • Manage internal and external stakeholders to advance scientific and technical capabilities in precision medicine.
  • Contribute to local and/or global process improvements that have a significant impact on business.
  • Ensure compliance with established practices, policies, processes, and regulatory requirements.

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.
  • In-depth knowledge of relevant health authorities and ability to represent Gilead in key interactions.
  • Strong analytical thinking skills, attention-to-detail, and communication and writing skills.
  • Ability to lead and influence programs, projects, and initiatives.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We are committed to advancing the care of patients worldwide through our portfolio of products and pipeline of investigational therapies.

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