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Associate Regulatory Affairs

Middlesex UB8 1DH   •  Contract/Temporary, Full time

CK Group are recruiting for an Associate Regulatory Affairs to join a biopharmaceutical company based either from home or at their site based in Uxbridge on a contract basis for 12 months.

Our client is committed to unlocking the potential of biology for patients


Associate Regulatory Affairs Role:

  • The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trialsin the EU.
  • Ensure compliance via timely submissions to regulatory agencies.
  • Coordinate collection of functional documents in support of regulatory applications. Coordinate QC of regulatory documentation (e.g. briefing packages).
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies.
  • Complete regulatory forms to support agency communications (e.g. EudraCT).

Your Background:

  • Good communication skills - oral and written.
  • Organizational skills.
  • Understanding of drug development process.
  • Previous experience in pharmaceutical industry of at least 1 year is preferred in a regulatory affairs department.

Quote job ref 48735.

It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 48735
  • Posted: 9th October 2020
  • Expires: 6th November 2020

CK Group

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