Regulatory Associate

Location
Cambridge
Salary
Up to £25.40 PAYE
Posted
30 Apr 2021
Closes
30 May 2021
Ref
50513
Contact
Lucy Stendall
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
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 as part 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 to prepare 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. Please quote reference 50513.

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