RA Specialist_Georgia

Preparation and submission of registration dossier for medicinal products, Submission of variations for medicinal products, Submission of renewal application, in line with CRO and EU regulations for medicinal products, Monitoring and reporting of legislation for the area of work, Participation in the development of SOPs, work instructions, etc., Participation in the development, review and revision of the SmPC and PIL, Communication with clients/contractor companies, Conducting registration procedures of medical devices, food supplements and cosmetic and coordinating registration procedures with business partners, Communication on behalf of a client with regulatory authorities, Advising clients on the current requirements of the legislation in the area of medicinal products, medical devices, cosmetics and food supplements.