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Regulatory Affairs Consultant

Cambridge, Cambridgeshire   •  £0 - £28.33 per hour  •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company on a remote basis, but with some occasional visits to their site based in Cambridge for a 12 month contract.

Paying up to £28.33 PAYE or £37.67 per hour Umbrella

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

The company have been based on the Cambridge science park for the past 25 years. It is easily accessed by car from A14/M11 and short distance from the A1. They are approximately 1 mile from the Cambridge North station.

Regulatory Affairs consultant role:
An affiliate Regulatory Affairs role, the Regulatory Affairs Consultant will be responsible for the local coordination and execution of regulatory submissions in compliance with corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.
Reporting to the Regulatory Director for UK and Ireland, the core elements of this pivotal role will be to support and execute local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application (CTA) submissions and regulatory support for the UK and Ireland affiliate commercial activities.

Key skills/experience:

  • Relevant Bachelor?s degree is essential
  • Experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
  • Knowledge and awareness of the relevant regulatory guidelines and legislation
  • Strong communication skills both oral and written
  • Organizational skills & regulatory project management skills

Preferred Qualifications and Experience:

  • Experience gained within a biologics organisation
  • Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53890 in all correspondence. 

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 53890
  • Posted: 17th June 2022
  • Expires: 15th July 2022

CK Group

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