Senior Regulatory Affairs Consultant

£60000 - £65000 per annum
26 Feb 2021
28 Mar 2021
Andy Leake
Healthcare, Consultant
Full Time
Contract Type
Experience Level
Senior Management
CK Clinical are recruiting for a Senior Regulatory Affairs Consultant to join a global Life Science consultancy on a permanent basis. This company works with a range of clients, driving innovation for the benefit of patients. This role will be based in Cambridge or Camberley with flexible home working.

Senior Regulatory Affairs Consultant Role:
The Senior Regulatory Affairs Consultant will provide expert advice to clients on projects, contributing to the design, implementation and execution of regulatory strategy.

  • Contribute to the definition and implementation of regulatory strategies for development of innovative products, drugs and biologics.
  • Write, review and assemble high quality regulatory submissions, such as, (but not limited to): Orphan Drug Designations (ODDs), Scientific Advice / Agency meeting briefing documents, Paediatric Investigational Plans (PIPs), etc.
  • Preparation and submission of Marketing Authorisation Applications (MAAs).
  • Manage Variations and Extensions applications for Centrally and UK-approved products.
  • Ensure compliance with EU, EMA and UK MHRA regulations and applicable guidelines.
  • Provide expert advice on Brexit related activities and regulations.
Your Background:
  • At least a University degree in a scientific discipline.
  • Extensive Regulatory experience within the pharmaceutical industry, mainly within development and clinical trials.
  • Proven ability to develop and implement regulatory strategy.
  • Demonstrated experience managing and executing submissions.
  • Experience writing regulatory documents.
  • BREXIT experience is a bonus.
  • Experience in consulting is preferable.
To apply:
Please quote reference 49985.