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Regulatory Affairs

  1. East Anglia
Buckinghamshire
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
35359
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EMEA Regulatory Affairs - Reguatory Consultant - Pharmaceuticals - 12-Month Contract

Our client has an exciting new opportunity for Regulatory Affairs Employee 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.
  • Development of regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products
  • supports the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate.
  • Supports the team with regional regulatory strategies in line with business plan for post-approval activities.
  • Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
  • 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.
  • Ensure Marketing Authorisations are maintained and renewed.

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
  • 2/3 days on site in High Wycombe

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

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