Belgrade Metropolitan Area
Regulatory Affairs professional with experience managing lifecycle activities for medicinal products and medical devices in the non-EU Balkan countries. I hold a Master's degree in Pharmacy and am currently pursuing a Postgraduate Master's (Master di Secondo Livello) in Development, Manufacturing, and Authorization of Biopharmaceuticals at the University of Modena and Reggio Emilia, strengthening my expertise in biopharmaceuticals and global regulatory requirements. I gained further international exposure through internships in Germany and Poland in clinical and social pharmacy, as well as health economics.
- Managed 26 Marketing Authorizations in Serbia and Montenegro for medicinal products in the therapeutic areas of oncology, hematology, immunotherapy, and rare diseases, ensuring compliance with both EU and local regulatory requirements - Managed regulatory submissions for new registration and renewal applications; - Managed product lifecycle through CMC and safety variations; - Maintained product information texts (SmPC, Leaflet, Labelling) - Reviewed and approved packaging and leaflet artworks to ensure regulatory compliance - Reviewed Module 3 content for multiple regulatory procedures and prepared Module 3 related responses to health authority queries - Monitored EMA, EDQM, ICH and local health authority guidelines to maintain up-to-date dossiers and workflow processes - Managed regulatory submissions for Class I and Class II medical devices - Liaised directly with health authorities in Serbia and Montenegro to expedite approvals and resolve queries - Provided regulatory consultancy to EU-based companies for extra-EU markets (Serbia and Montenegro) - Provided regulatory support to supply chain operations for the import of medicinal products, reference standards, and medical devices from the EU - Collaborated with cross-functional teams (Pharmacovigilance, QA, Supply, Sales) - Participated in internal, external and supplier audits - Maintained regulatory databases and archives (RIMS, CARA Generis) - Supported IDMP/SPOR implementation through structured data migration into the health authority database Therapeutic areas: oncology, hematology, rare diseases, immunotherapy Medical devices: Class I and Class II
Completed an obligatory internship for pre-licensed pharmacists: - Dispensed medicines, conducted therapy monitoring and interactions' screening - Counselled patients on prescribed medicine, OTC, medical devices and dermo cosmetics
Traineeship provided by the European Association of Hospital Pharmacists: - Worked in ISO-certified GMP-compliant galenic and aseptic manufacturing units (manufactured cytostatic and ophthalmic medicine; prefilled syringes for emergency care; pain management therapy, liquid and semi-liquid forms for personalized therapy) - Executed QC testing of manufactured products and QA oversight of in-house medications - Shadowed a clinical pharmacist at geriatrics and vascular surgery wards - Conducted medication reconciliation at the hospital admission
An international student internship completed at the Department of Social Pharmacy and Pharmacoeconomics: - Medication review - Quality of life assessment and basic pharmacoeconomic analysis - Preparation of drug leaflets for specific patients Mentor: dr hab. Agnieszka Skowron, prof. UJ.
Mentee in an international career-development project, together with 50 selected students from Europe: - Processed ICSRs and performed literature search - Attended educational courses and webinars in pharmacovigilance and regulatory affairs (GVP, Causality Assessment, medication errors, statistical methods in PV, quality by design and regulatory affairs in the generic drugs’ market) - Participated at career development events - End-of-the-project research work: "COVID-19 Vaccines: Evaluation, Approval and Monitoring in Europe" Mentor: MPharm Maria Mantziri