Regulatory Affairs Associate

37802
  • GBP £35,000.00
  • London, UK
  • Permanent

Walker Cole International is searching for a Regulatory Affairs Associate for a global pharmaceutical company based in the southeast of the UK. As a Regulatory Affairs Associate, you will be responsible for carrying out a range of activities to support existing and new MAA’s, submissions, life-cycle management, and compliance.

The main responsibilities of the Regulatory Affairs Associate will be:

  • Prepare and review regulatory applications for variations, and ownership change within the UK, EU, and Globally
  • Reviewing and supporting updates to existing Artwork and labelling (PIL, SmPC, mockups, CCDS)
  • Review of documentation and inquiries from CMO’s concerning MAA’s
  • Preparation and submission of eCTD/CTD dossiers to the relevant regulatory bodies

 

To be successful in your application for the Regulatory Affairs Associate opportunity, you will have:

  • A degree in Chemistry, Pharmacy, or relevant life science
  • Relevant and demonstrable experience in the relevant markets (UK/EU/Global)
  • Experience in working with generic/licensed medicines
  • Knowledge/Understanding of CMC/eCTD requirements

 

 

Regulatory Affairs | Regulatory Affairs Associate | RA | RAA | Pharmaceutical | New Product Development | NPD | Pharma | MHRA | Medicines | Generics | Prescription | Marketing Authorisation Application | MAA | Regulatory Strategy | Variations | Licensed Products | EU | MHRA | UK | Compliance | Artwork | eCTD | Electronic Common Technical Document | CTD | Common Technical Document | SmPC | PIL | Patient Information Leaflet | Variations | Module 3 | Compliance | CCDS | Company Core Data Sheet |

Christopher Sowden Founding Director

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