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 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.

Responsibilities:

• 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.