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EMEA Regulatory Affairs

  1. East Anglia
Buckingham
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
34584

This vacancy has now expired

EMEA Regulatory Affairs Contract or- Pharmaceuticals - 6-Month Contract

Our client have an exciting new opportunity for a regulatory affairs contractor to join the team. Our client has specialised in pharmaceutical products and people's well-being for over a century and work with some well-known household brands. 


Responsibilities: 
  • Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS) procedures for CMC and non-CMC variation, when WS is appropriate.
  • Supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  • Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
  • Prepares and compiles regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • EAME databases (RegPoint, HAQ) are fully maintained.

Requirements: 
  • Life sciences or chemistry graduate to honours level or equivalent.
  • Works with minimal supervision to plan, conduct, and manage regulatory submissions for European procedures and multiple projects to meet department and company objectives.
  • Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
  • Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc
  • Hybrid. 1 - 2 days in the office per week

If this role is of interest to you, please apply now!

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