- Preparing application for obtaining the marketing authorization, renewals and variation for the already approved Medicines in Serbia. - Take part in process of organizing work regarding control labeling- Preparing local SmPC, PIL, and labelling - Market Access (Pricing&Reimbursement)- Local QPPV Deputy;

- Preparing application for obtaining the marketing authorization, renewals and variation for the already approved Medicines in Serbia. - Registration/Renewals of Medical Devices in Serbia. - Registration/Renewals of Food Suplements in Serbia. - Take part in process of organizing work regarding control and aditional labeling- Preparing local SmPC, PIL, and labelling- Market Access (Pricing&Reimbursement)- Local QPPV Deputy;

- Preparing application for obtaining the marketing authorization, renewals and variation for the already approved Medicines in Serbia. Preparing and providing documentation for registration in Bosnia, Montenegro, Macedonia and Croatia- Registration of Medical Devices in Serbia. Preparing and providing documentation for registration in Bosnia, Montenegro, Macedonia and Croatia- Registration of Food Suplements in Serbia. Preparing and providing documentation for registration in Bosnia… Show more - Preparing application for obtaining the marketing authorization, renewals and variation for the already approved Medicines in Serbia. Preparing and providing documentation for registration in Bosnia, Montenegro, Macedonia and Croatia- Registration of Medical Devices in Serbia. Preparing and providing documentation for registration in Bosnia, Montenegro, Macedonia and Croatia- Registration of Food Suplements in Serbia. Preparing and providing documentation for registration in Bosnia, Montenegro, Macedonia and Croatia- Take part in process of organizing work regarding control labeling- Preparing local SmPC, PIL, and labelling - Market Access (Pricing&Reimbursement)- Local QPPV Deputy; Show less

-Planning and organising production schedules-Overseeing production processes.-Registration of dietary supplements-Draft quality assurance policies and procedures-Review the implementation and efficiency of quality and inspection systems-Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality-Analyze data to identify areas for improvement in the quality system-Responsible for document management… Show more -Planning and organising production schedules-Overseeing production processes.-Registration of dietary supplements-Draft quality assurance policies and procedures-Review the implementation and efficiency of quality and inspection systems-Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality-Analyze data to identify areas for improvement in the quality system-Responsible for document management systems-Planning, coordinating and monitoring the receipt, order assembly and dispatch of goods-Keeping stock control systems up to date and making sure inventories are accurate-Organising the recruitment and training of staff, as well as monitoring staff performance and progress-Maintaining standards of health and safety, hygiene and security in the work environment-Preparing application for obtaining the marketing authorization, renewals and variation for the already approved documentation-Local QPPV deputy Show less

- Preparing application for obtaining the marketing authorization, renewals and variation for the already approved documentation- Take part in process of organizing work regarding control labeling- Preparing local SmPC, PIL, and labelling - Market Access (Pricing&Reimbursement)- Medical affairs: Promo materials, MIR, Medico-marketing projects.- Local QPPV Deputy;

Regulatory Affairs Officer:Take part in preparing application for obtaining the marketing authorization, renewals and variation for the already approved documentation, for a medicinal product of Teva Pharmaceuticals Industries Ltd. and its affiliatesTake part in process of organising work regarding additional and control labelingTake part in process of preparing local SmPC, PIL, and labelling Responsible person for control labelling:Organising work regarding control… Show more Regulatory Affairs Officer:Take part in preparing application for obtaining the marketing authorization, renewals and variation for the already approved documentation, for a medicinal product of Teva Pharmaceuticals Industries Ltd. and its affiliatesTake part in process of organising work regarding additional and control labelingTake part in process of preparing local SmPC, PIL, and labelling Responsible person for control labelling:Organising work regarding control labeling (submitting request for control stamps, sending cotrol stamps to sites, record documentation regarding request and sending, reporting)LSO (local safety officer) deputyResponsible for Pharmacovigilance in case when LSO (local safety officer) is absentSubmitting Periodic Safety Update Reports (PSURs), ASRDocumentation, collecting, assessment and archiving of ADR reports (local & global)Performing follow-up, if necessaryForwarding domestic ADR reports to Agency for medicines and medical devices in Serbian language and to relevant PhV Data Entry Unit, in English languageReceiving the CIOMS-I form from Global PhV department for all TEVA products registered in Serbia (for valid MA and at least 6 months after MA expiry) and forwarding to relevant local regulatory authority institutionsForwarding to the PhV data entry unit all domestic ADR reports collected in Serbia Show less

Working on formulation of pharmaceutical product, and preparing application documentation for regulatory approval for new medical products, renewals and variations. I was working on preparation of local SmPC and PIL. My job also includes business correspondence with partners from abroad.

As a representative of wholesale Fabeg Filiapharm, I made contracts with various clients