Ensure that day-to-day PV functions are performed satisfactorily and that optimal regulatory compliance is maintained at the affiliate level- Coordinate the delivery of a comprehensive PV service and maintain standards for regulatory reporting requirements- Act as local person responsible for PV as defined by local regulation- Maintain overall responsibility for the coordination of safety reporting requirements- Write, validate and implement the local operating procedures/guidelines and verify adherence- Accountable for the collection, review and reporting of Adverse Events (AEs) reports obtained through spontaneous reporting, PM clinical study reports, local literature, Local Health Authorities (HAs) and all other potential sourcesRA - Support Regulatory activities regarding Serbia and Montenegro MA, renewal, variations and labelling.QA - SOPs, WI and Quality compliance

Writing, compiling and updating Module 3 and Module 2 – Quality overall summary of registration dossier, evaluation documentation for regulatory approval for new medicinal products, renewals and variations

Preparation of dossier for the registration, variation or renewal application of medicinal products. Preparation SmPC, PIL, labelling for the registration submissions, according to the good regulatory practice. Prepares Type I and Type II variations for all marketed medicinal products and ensures the timely submission of variations in accordance with local regulatory requirements. Obtains all the necessary certificates and documents, and prepares application dossier for registration of medical devices and for renewals and variations procedures.

Medical e-database screening and PSUR writing

Organization, monitoring and approval of of all production steps: raw material supply, preparation of solutions, filling, labelling and final packaging.