Regulatory Global Lead

  • Salary: £80,000 per annum
  • REF Number: 00048586
  • Consultant: Robert Angrave
  • Contact: 01438 870022
  • Date Published: 29.07.2020
  • Sector: Oncology
  • Location: Welwyn Garden City, South East, Home Counties
  • Discipline: Regulatory Affairs

CK Clinical are recruiting for a Regulatory Group Lead to join a pharmaceutical company who are based in Welwyn Garden City.

Regulatory Group Lead Role: The main purpose of the role will be to:

  • Drive regulatory strategy and oversight of implementation/execution in alignment.
  • Act as primary contact point for any regulatory questions related to the assigned projects and/or assets, and support any key interactions with health authorities.
  • Be accountable for the timely development and implementation of the regulatory strategy and plan(s) in relation to EU exit.

Further responsibilities will include:

  • Accountability for the review of submission key documents and ensuring global alignment.
  • Participating and contributing to global strategic initiatives and tactical plans related to the gathering and analyses of customer insights.
  • Line management and mentorship within the team.
  • Assisting in regulatory initiatives leading to process improvement and development.

Your Background: To succeed in this role, you will:

  • Come from a Life Science background and have work experience in Regulatory Affairs.
  • Have knowledge of regulatory procedures & legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension & license maintenance.
  • UK and Ireland regulatory experience is a plus.

Apply: For more information or to apply for this Regulatory Group Lead position, please contact Rob Angrave on 01438 870022 or email rangrave@ckclinical.co.uk, quoting job ref 48586.

It is essential that applicants hold entitlement to work in the UK.

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