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