Senior Regulatory Affairs Consultant
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 basedin 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 executionof 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.
- 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: It is essential that applicants hold entitlement towork in the UK. For more information or to apply for this Senior Regulatory Affairs Consultant position, please contact Andy Leake on 01438 842 966 or firstname.lastname@example.org. Please quote reference 49985.