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Regulatory Affairs Associate

Middlesex   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Specialist to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.

Hourly: £15.54 PAYE or £20.22 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.

Uxbridge. This site is a Development Centre which was opened 2007. It is located in the heart of the biopharma community west of London. It is ideally situated for easy access to all that central London has to offer.

As a PAYE employee you will be entitled to receive:
? Weekly/monthly payroll options
? Pension
? Timesheet system
? Bike schemes

Regulatory Affairs Specialist Role:
- Provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.
- Support may include organizing, managing and executing on regulatory CMC projects and submissions.
- Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.

Your Background:
- Degree in life sciences, biochemistry, or chemistry
- Experience in biopharmaceutical or pharmaceutical industry
- Familiarity with eCTD structure
- Motivated with initiative to learn quickly
- Experience in CMC, including preparation of submissions to Agencies

Apply: It is essential that applicants hold entitlement to work in the UK. Please quote reference 53607.

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

  • Agency: CK Group
  • Reference: 53607
  • Posted: 9th May 2022
  • Expires: 6th June 2022

CK Group

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