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
- 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.
Entitlement to work in the UK is essential. For more information, please contact Lucy Stendall on 01246 457739 or email firstname.lastname@example.org. Please quote reference 50513.