Associate Regulatory Affairs

  • Salary: Competitive
  • REF Number: 00048735
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 09.10.2020
  • Sector:
  • Location: Remote, South East
  • Discipline:

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.

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

Salary: Competitive

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.

Apply: For more information or to apply for this Associate Regulatory Affairs position, please contact Lucy or Andy on 01246 457725 or email, quoting job ref 48735.

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

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