Senior Regulatory Affairs Consultant

£60000 - £65000 per annum
27 Apr 2021
27 May 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.

Apply for Senior Regulatory Affairs Consultant

Already uploaded your CV? Sign in to apply instantly


Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB

4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.

When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.