• Regulatory projects management throughout the entire project lifecycle • Scientific assessment of quality (CMC) and efficacy (BE) documentation for generic drug products as a prerequisite for addition to the company’s portfolio • Organisation of Regulatory affairs activities within the company• Active participation in business and strategic development

• Scientific assessment of quality (CMC) and efficacy (BE) documentation for generic drug products as a prerequisite for addition to the company’s portfolio • Regulatory affairs activities • Change control management• Preparation and revision of standard operating procedures

• Regulatory projects management throughout the entire project lifecycle for innovative and generic drug products• Evaluation of quality (CMC) and efficacy (BE) documentation for generic drug products as a prerequisite for addition to the company’s portfolio • Regulatory affairs activities (Marketing Authorisation Applications, Renewals, Variations, Scientific advices)• Main point of contact for clients and drug agencies • Promotional materials review and approval• Change control management• Preparation and revision of standard operating procedures

Senior Assessor of Bioequivalence studies • Assessment of bioequivalence (BE) studies including clinical, analytical, pharmacokinetic and statistical part of documentation• Evaluation of biowaiver applicationsSenior Assessor in National Pharmacovigilance Centre • Assessment of periodic safety update reports (PSUR)• Assessment of risk management plan (RMP)• Evaluation of individual case safety reports (ICSR), cumulative safety reports, detection of safety signals, and processing data into the national and the WHO database including MedDRA coding• Assessment of postmarketing changes in SmPC/PIL (safety variations)• Participating in the work of the Committee for marketing authorisation of human medicines and herbal medicines • Member of a Twinning Project between French Health Product Safety Agency (AFSSAPS) and Medicines and Medical Devices Agency of Serbia (ALIMS) in Pharmacovigilance field and Benchmarking European Medicines Agencies. Project was EU-funded and was organized with a purpose of building up new regulatory framework in Serbia and capacity building of ALIMS Senior Assessor in Pharmaceutical Department • Assessment of quality documentation (registrations/renewals/variations)• Participating in the work of the Committee for marketing authorisation of human medicines• Member of the Committee for National Pharmacopoeia

Department of Pharmaceutical Technology Teaching and research assistant • Practical aspects in pharmaceutical technology and biopharmaceutics (work with students)