- 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