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.
- 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.
Please quote reference 49985.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Andy Leake
- Phone: 01438 743047
- Reference: 49985
Website: CK Group
- Posted: 27th April 2021
- Expires: 25th May 2021