Experience

Pharmassistance LLC

• Belarus
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Regulatory specialist

  • May 2021 - Present

  - Provide submission strategy to the client along with all requirements and documentation; - Provide the client and the internal team information on regulations and drug considerations at a project level and answer client questions surrounding these; - Organize all regulatory activities, including product registration and post registration maintenance; - Organize dossiers’ preparation as well as timely submissions and approvals in accordance with approved work plan; - Registration, variations, renewals of medicinal products according to national legislation in the Republic of Belarus; - EAEU regulatory activities in Belarus and Russia (registration, variations, alignment); - Supervision and control of the registration process until the receipt of the MA, including preparation of responses to the requests issued by the Regulatory Authorities within the time limits established by the procedure; - Preparation of all necessary documents for dossier's submission, including development of local SPC, PIL and artworks; - Сoordination of samples import for laboratory control; - Communication with the Authorities, Expert Institutions and other relevant organizations; - Organization of GMP inspection for compliance of EAEU requirements; - Registration of medicinal products in different dosage forms and nature, including biologics products (vaccine, recombinant proteins); - Managing multiple activities; - Reporting, following internal plan of registrations, keeping the Regulatory Affairs documentation systems compliant and up-to-date; maintenance of the electronic archive of the RA documents; - Support the development of new processes and SOPs updates. Show less



Foreign Production and Trade Unitary Enterprise "Reb-Pharma"

• Regulatory Affairs Specialist

  • Mar 2021 - May 2021

  - Organize all regulatory activities for registration, variations, renewals of medicinal products according to national legislation in the Republic of Belarus; - Control of financial documentation, agreements; - Archiving of the documentation at the Registration Department - Organize all regulatory activities for registration, variations, renewals of medicinal products according to national legislation in the Republic of Belarus; - Control of financial documentation, agreements; - Archiving of the documentation at the Registration Department



JLLC "TriplePharm". Pharmaceutical Сompany

• Belarus
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead Specialist of Development, Registration and Standardization Department

  • Jul 2017 - Mar 2021

  - Regulatory affairs management for Belarus, Russia, Uzbekistan, Tajikistan, Kyrgyzstan, Georgia - Preparation and submission of the Registration Dossier for medicinal products/API/ medical devices; - Supervision and control of the registration process until the receipt of the MA; - Preparation and submission of samples together with the relevant package of documentation for the pharmaceutical expertise; - Communication with the Authorities, Expert Institutions and other relevant organizations; - Preparation of layout designs; - Participation in the pharmaceutical development of medicinal products; - Reporting, following plan of registrations, SOPs updates, archiving of the documentation at the Registration Department; - Coordination of the Registration & Logistics Department’s activity; - Сontrol of financial documentation, agreements; - Provide mentoring and training for less experienced team members. Show less