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Regulatory Affairs Director

2 months ago

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

About the Role

We are seeking an experienced Regulatory Affairs professional to join our global team at Gilead Sciences International, Ltd.

Key Responsibilities

  • Develop and implement regulatory strategies for assigned products or projects.
  • Collaborate with cross-functional teams to shape dossier content for global rollout and life cycle management.
  • Oversee the preparation and maintenance of CMC regulatory submissions.
  • Provide strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
  • Participate in sub-teams and proactively identify regulatory or related risks/issues.

Requirements

  • Strong life sciences background, ideally in cell & gene therapy.
  • In-depth knowledge of current global and regional trends in biologics and cell and gene therapy regulatory affairs.
  • Excellent knowledge of Microsoft Office tools and the Veeva platform quality/regulatory/compliance systems.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
  • Demonstrated ability to learn quickly while being flexible and adaptable to change.

What We Offer

We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.