Regulatory Affairs Project Manager

  • Salary: £50,000 - £80,000
  • REF Number: 00048017
  • Consultant: Robert Angrave
  • Contact: 01438 870022
  • Date Published: 16.04.2020
  • Sector: Oncology
  • Location: Macclesfield, North West
  • Discipline: Regulatory Affairs

CK Clinical are recruiting for a Regulatory Affairs Project Manager to join a pharmaceutical company focused on Oncology studies on a permanent basis, who are relocating to the Cheshire area.

The Role:

The main purpose of the role will be to:

  • Project manage regulatory submissions to EMA and interactions with the agency.
  • Oversee publishing of all electronic regulatory submissions, including management of external providers.
  • Provide guidance on EMA requirements.
  • Serve as an EMA correspondent.
  • Regulatory submission SOPs and other guidelines, communicating updates and information as appropriate.

Your Background:

  • Bachelor's degree in a scientific discipline.
  • 5+ years of experience in a regulatory affairs role, including EMA experience.
  • Thorough working knowledge of regulatory agency requirements (EMA, FDA) and ICH, with successful experience of global clinical trial and marketing applications.
  • Ability to liaise with regulatory agencies.
  • Drug development knowledge, with oncology-specific experience highly desired.
  • Knowledge of GCP, GMP and GLP.

For more information or to apply for this Regulatory Affairs Project Manager position, please contact Rob Angrave on 01438 870022 or email rangrave@ckclinical.co.uk, quoting job ref 48017.

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

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