Myroslava Yaremenko
Reinach
Summary
Regulatory Affairs Specialist with a proven track record of ensuring compliance with FDA, EMA, and other regulatory agencies' guidelines. Proficient in drug registration processes, adept at developing regulatory strategies to facilitate product approval and market access. Strong collaborator, able to work effectively across departments and communicate complex regulatory concepts.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist
The State Expert Center Of The Ministry Of Health
07.2018 - 02.2022
- Conducted expert work entailed assessing the viability of drug registration within Ukraine's regulatory framework.
Committee Member
Expert Committee
09.2017 - 06.2018
- Participated in the work of the Expert Committee on Selection and Use of Essential Medicines, including its meetings and discussions on agenda items.
- Conducted expertise regarding the assessment of comparative effectiveness, safety, and economic feasibility of medicinal products for proposed amendments to the National List of Essential Medicines.
Expert
The State Expert Center Of MOH Of Ukraine
08.2016 - 07.2018
- Conducted expert assessments regarding the possibility of inclusion/exclusion of a medicinal product into/from the State Formulary.
- Analyzed statistical data on the presence of international non-proprietary names, trade names in the State Formulary according to the ATC classification.
Head of the Secretariat
Expert Committee
12.2016 - 08.2017
- Implemented organizational support for the functioning of the Expert Committee on Selection and Use of Essential Medicines.
- Coordinated the search for information necessary for assessing the comparative effectiveness, safety, and economic feasibility of medicinal products.
- Facilitated the inclusion process of medicinal products in the National List of Essential Medicines.
Senior Specialist
The State Expert Center Of MOH Of Ukraine
05.2013 - 07.2016
- Conducted expert assessments regarding the possibility of inclusion/exclusion of a medicinal product into/from the State Formulary.
- Analyzed statistical data on the presence of international non-proprietary names, and trade names in the State Formulary according to the ATC classification.
Pharmacy Manager
Falbi LLC
01.2011 - 04.2013
- Oversaw documentation management, inventory control, personnel supervision, staff training, and cashier document handling within the Materials Examination Department specializing in Rational Pharmacotherapy Issues.
Pharmacist
Falbi LLC
07.2004 - 01.2011
- Dispensed pharmaceuticals and medical products to customers and managed cashier documents.
Education
Training - General Pharmacy
Ukrainian Military Medical Academy
Kyiv, Ukraine04.2018
Continuing Education - General Pharmacy
Shupyk National Healthcare University of Ukraine
Kyiv, Ukraine2010
Master's Degree -
Ukrainian Military Medical Academy
Kyiv, Ukraine2006
Internship -
Ukrainian Military Medical Academy
Kyiv, Ukraine2005
Bachelor's Degree - Pharmaceutics
Bogomolets National Medical University
Kyiv, Ukraine2004
Skills
- Post-marketing surveillance
- Regulatory Submissions
- Labeling and Packaging
- CAPA Management
Languages
Ukrainian
Native language
English
Upper intermediate
B2
German
Elementary
A2
Certification
- August 2016 - Completed training on "Standard Operating Procedures" organized by the Systems for Improved Access to Pharmaceuticals and Services Program (SIAPS).
- July 2016 - Completed training on "Medical Technology Assessment" organized by the Systems for Improved Access to Pharmaceuticals and Services Program (SIAPS).
- November 2015 - Completed the regional educational program "Modern Requirements for Pharmacoeconomics Research" organized by the European Bureau of the World Health Organization, Chisinau, Moldova.
Timeline
Regulatory Affairs Specialist
The State Expert Center Of The Ministry Of Health
07.2018 - 02.2022
Committee Member
Expert Committee
09.2017 - 06.2018
Head of the Secretariat
Expert Committee
12.2016 - 08.2017
Expert
The State Expert Center Of MOH Of Ukraine
08.2016 - 07.2018
Senior Specialist
The State Expert Center Of MOH Of Ukraine
05.2013 - 07.2016
Pharmacy Manager
Falbi LLC
01.2011 - 04.2013
Pharmacist
Falbi LLC
07.2004 - 01.2011
Training - General Pharmacy
Ukrainian Military Medical Academy
Continuing Education - General Pharmacy
Shupyk National Healthcare University of Ukraine
Master's Degree -
Ukrainian Military Medical Academy
Internship -
Ukrainian Military Medical Academy
Bachelor's Degree - Pharmaceutics
Bogomolets National Medical University
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