Regulatory Affairs Director, Precision Medicine

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.
  • Support or lead training related to IVD/CDx development and registration activities.
  • 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 their requirements.
  • Strong analytical thinking skills, attention-to-detail, and communication and writing skills.
  • Ability to lead and influence programs, projects, and 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.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a biopharmaceutical company that discovers, develops, and commercializes innovative therapies for complex, life-threatening diseases. We are committed to making a difference in the lives of patients and communities around the world.

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