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, quoting job ref 48017.

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

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.