Regulatory Associate

  • Salary: Up to £25.40 PAYE
  • REF Number: 00050513
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 30.04.2021
  • Sector: Non-Specific
  • Location: Cambridge, East Anglia, Home/Field Based
  • Discipline: Regulatory Affairs

CK Group are recruiting for a Regulatory Associate to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 11 months.

Salary: Up to £25.40 PAYE depending on experience

Regulatory Associate Role:

  • Work aspart of a global Regulatory Operations team, contributing to global filings
  • Lead key submissions for EU, Switzerland and Emerging Markets
  • Compilation and publishing of submission dossiers for Europe and the extended EU markets for clinical trials, paediatrics and marketing applications according to regional regulatory agency guidance
  • Work closely with submission content providers to advise on submission content, structure, planning and strategy
  • Submission management of publishing tasks sent to publishing vendors

Your Background:

  • Degree or equivalent combination of experience and knowledge
  • Demonstrated regulatory publishing experience within the pharmaceutical industry;
  • Use of specialist publishing software toprepare submissions - Insight Publisher preferred
  • Use of electronic document management systems
  • Understanding of Regulatory submission requirements

Company: 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.

Location: This Regulatory Associate role will be based at our clients site in Cambridge.

Apply:

Entitlement to work in the UK is essential. For more information, please contact Lucy Stendall on 01246 457739 or email pharmacontracts@ckagroup.co.uk. Please quote reference 50513.

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