• Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP)
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes including MHRA and HPRA
  • Management of artwork generation
  • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), DocuBridge
  • Building the submission backbone and handover to RegOps for Publishing;
  • Submit Published packed via CESP/national portal.
  • Follow-up with the authorities and close out changes (inform affiliates etc.), track approvals, update RA tools


    • knowledge and experience in regulatory submission activities within the EEA, focus: Lifecycle management (variations, renewals, etc.)
    • experience in regulatory affairs within the generic industry (large portfolio, high number of products to be handled)
    • experience in the handling of eCTD dossiers
    • experience in change control activities within the pharmaceutical environment
    • solid command of English
    • highly flexible and adaptable personality
    • strong team player qualities

755 Regulatory Affairs Manager