PHARMASSIST LTDRegulatory Affairs Officer
May. 2023Athens, Attiki, GreeceMy experience lies on: *Handling of Marketing Authorization applications, variation and renewal procedures submitted via MRP, DCP, CP & NPs.
*Preparation of Module 1 documents for the above procedures
*Communications with Health Authorities during the procedures mentioned and submitting Responses to Deficiency Letters, ensuring successful End of Procedure.
*Compilation of eCTD dossiers (especially for Modules 1-3)
*Communication with Stakeholders for the preparation and submission of required documentation during Initial Registrations, Variations, Renewals in EU and RoW markets.
*Reviewing and preparation of Mock-ups & Product Information materials
*Reviewing and providing feedback on approval/rejection of Promotional Materials
*Monitoring of Greek and EU legislation & guidelines
*Maintaining and updating internal databases ensuring compliance and readiness for Internal/External Audits
*Experienced using Platforms/Software managing Regulatory Content & Data such as Veeva Vault, Webcenter.