Dmytro Kosyi

Experience

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  Biopharma Plasma

  Feb 2017 - Jan 2019

  - conduct regulatory procedures (full cycle);- ensuring compliance of handling, submission and sharing information regarding renewals, variations and other regulatory affairs (artworks creation, monitoring of regulation changes);- placement the layouts (artworks) of the primary or/and secondary packaging and approved registration documents in the Unified Automated Information System of the State Service of Ukraine on Medicines and Drugs Control;- conducting other regulatory procedures: preparation of documentation for the import of unregistered APIs into Ukraine; preparation of documentation on changing the status of advertising of medical products; preparation and aligning agreements between company and State expert center or with 3rd parties;- cooperation with Ukrainian Medical Center of Certification (UMCC) in relation to registration medical devices (preparing documents in according to Decree of the Cabinet of Ministers of Ukraine №753, participation in audit of quality management system by UMCC);- cooperation with the Institute of Ecohygiene and Toxicology and with the Institute of Public Health in relation to obtaining safety conclusions for dietary supplements;- cooperation with State Enterprise «Ukrtestmetrstandart» in relation to Technical condition for Dietary supplements and Medical devices;- control and planning of the work of specialists of registration and supporting with complicated tasks;- participation in the planning of the launch of a new products (cooperation with the marketing department, with supply chain, with global colleagues from manufacturing sites);- renewal and update conclusions of GMP certificate recognitions; participation in the procedure of certify the manufacturing compliance with the GMP requirements (preparation of documentation in accordance with the Order of the Ministry of Health №1130), cooperation with SE “Central laboratory” and with SE “Ukrainian institute of quality”, namely with experts and with inspectors; Show less - conduct regulatory procedures (full cycle) of state registration (MoH order 426), renewals, variations and amendment procedures;- ensuring compliance of handling, submission and sharing information regarding renewals, variations and other regulatory affairs (artworks creation, monitoring of regulation changes);- placement the layouts (artworks) of the primary or/and secondary packaging and approved registration documents in the Unified Automated Information System of the State Service of Ukraine on Medicines and Drugs Control;- conducting other regulatory procedures: preparation of documentation for the import of unregistered APIs into Ukraine; preparation of documentation on changing the status of advertising of medical products; preparation and aligning agreements between company and State expert center or with 3rd parties;- cooperation with Ukrainian Medical Center of Certification (UMCC) in relation to registration medical devices (preparing documents in according to Decree of the Cabinet of Ministers of Ukraine №753, participation in audit of quality management system by UMCC);- cooperation with the Institute of Ecohygiene and Toxicology and with the Institute of Public Health in relation to obtaining safety conclusions for dietary supplements. Show less

  • DRA Manager

    May 2018 - Jan 2019

  • DRA Specialist

    Feb 2017 - May 2018
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  Novartis

  Feb 2019 - Dec 2023

  DRA Specialist

  - conduct regulatory procedures (full cycle) of state registration (MoH order 426, MoH order 1245), renewals, variations and amendment procedures;- ensuring compliance of handling, submission and sharing information regarding renewals, variations, pharmacovigilance (RMP, PSUR, ACO) and other regulatory affairs (artworks creation, monitoring of regulation changes);- renewal and update conclusions of GMP certificate recognitions; participation in the procedure of certify the manufacturing compliance with the GMP requirements (preparation of documentation in accordance with the Order of the Ministry of Health №1130), cooperation with SE “Central laboratory” and with SE “Ukrainian institute of quality”, namely with experts and with inspectors;- placement the layouts (artworks) of the primary or/and secondary packaging and approved registration documents in the Unified Automated Information System of the State Service of Ukraine on Medicines and Drugs Control. Show less

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  Acino

  Dec 2023 - now

  Global Regulatory Affairs Manager

  Maintain global RA activities related to aligning, preparing, compilation and distribution of the dossiers, in particular in the eCTD format. Conducting regulatory procedures in the EU/CH.Updating all relevant databases: document management, RIM, change control and artwork management systems.Collaboration with regional RA and other functions on regulatory projects.