Regulatory Affairs Lead

2 months ago

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

Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC.

In this role, you will be responsible for leading the regulatory strategy and submissions for Kite's existing commercial and/or clinical programs within the EU region. You will collaborate closely with headquarters colleagues to ensure a seamless global rollout and life cycle management of products in EU-aligned regions.

Your Responsibilities
  • Serve as the primary point of contact for regulatory authorities in the EU, overseeing the preparation and maintenance of CMC regulatory submissions for assigned products or projects.
  • Define and implement comprehensive regulatory strategies, plans, and objectives for assigned products or projects, ensuring alignment with global regulatory requirements.
  • Lead cross-functional teams to develop and submit high-quality regulatory dossiers, including meeting requests, briefing packages, investigational medicinal product dossiers (IMPDs), variations to the commercial marketing authorization, and substantial modifications to clinical trials.
  • Provide strategic guidance and support to Regulatory Affairs colleagues and cross-functional teams, ensuring compliance with all applicable regulations and guidelines.
  • Actively participate in ad hoc projects aimed at continuously improving or advancing regulatory affairs capabilities within the organization.
Your Profile

We are looking for a highly skilled and experienced individual with a strong understanding of CMC regulatory affairs, particularly in the cell and gene therapy space.

  • Possess a degree in life sciences and significant relevant experience in CMC related regulatory affairs.
  • Demonstrate a deep understanding of current global and regional trends in biologics and cell & gene therapy regulatory affairs, with proven success applying this knowledge to optimize team delivery and results.
  • Exhibit strong leadership presence with the ability to lead without authority and influence programs, projects, and initiatives within a highly matrixed environment.
  • Possess excellent communication, interpersonal, and organizational skills, with a demonstrated ability to work effectively in a fast-paced and collaborative setting.

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