Regulatory Affairs Director

5 days ago

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

Job Summary

Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC. In this role, you will be responsible for defining the regulatory strategy, plans, and objectives for assigned products or projects.

Key Responsibilities

  • Act as one of the EU Regulatory leads for Kite's existing commercial and/or clinical programs.
  • Define the regulatory strategy, plans, and objectives for assigned products or projects.
  • Contribute to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies, and capabilities.
  • Take the lead on CMC submissions and collaborate with headquarters' colleagues to shape dossier content for global rollout and life cycle management in EU-aligned regions.
  • Oversee the preparation and maintenance of CMC regulatory submissions for assigned products or projects, guiding and advising colleagues to ensure thorough and compliant completion of these activities.
  • Play a leadership role in ad hoc or special projects aimed at continuously improving or advancing Regulatory Affairs capabilities.

Requirements

  • Strong life sciences background, ideally in cell & gene therapy.
  • In-depth knowledge of current global and regional trends in biologics but ideally also cell and gene therapy regulatory affairs.
  • In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives to support a team-oriented, highly matrixed environment.
  • Demonstrated ability to learn quickly while being flexible and adaptable to change, and to move between projects easily and provide support/expertise where needed.
  • Excellent knowledge of Microsoft Office tools and the Veeva platform quality/regulatory/compliance systems.

Equal Employment Opportunity (EEO)

Gilead Sciences International, Ltd. is an equal opportunity employer and welcomes applications from diverse candidates.

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