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Summary

As a medical/scientific/regulatory writer have an understanding of science and ability to write about it, bringing clarity to complex topics. Meticulous attention to detail and ability to analyze both descriptive and numeric data. I participate in meetings related to planning of studies that are in progress or are planned. Manage the reviews and suggestions from different stakeholders. I provide scientific advice on development strategy, and provide project management of all regulatory requirements. Citizenship: Ukraine, the EU (Romania).

Experiences

Current Experience

  • Regulatory specialist in Preclinical&Clinical Trials Department
    Since February 2016
    Responsibilities: - Scientific advice providing - Preparation or maintain technical files as necessary to obtain product approval (clinical and non-clinical parts of CTD) - Writing literature reviews on clinical or pre-clinical studies, expert reports, substantiation reports, clinical evaluation reports for medical devices, SPCs, PILs, labels and investigators brochures, clinical eveluation reports for MD - Transformation of data and information into a format that meets clinical regulatory document requirements - Preparation of additional information or responses as requested by regulatory agencies - Conducting systematic literature searches - Interpretation regulatory rules or rule changes as well as ensure that they are communicated through corporate policies procedures - Providing technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and also clarity of presentation - Coordinating, preparation, or reviewing regulatory submissions for domestic or international projects - Participating in the planning and management of non-clinical/clinical trials. - Interpretation of literature information and makes recommendations for application to clinical regulatory documents.

Past Experience

  • lecturer of pharmacology
    September 2010 --- December 2016
    Responsibilities: training curriculum, lecturing, conducting seminars, compilation of teaching aids

  • Regulatory Affairs Specialist in the Regulatory Affairs Department
    June 2012 --- February 2016
    • Prepare or maintain technical files as necessary to obtain sustain product approval (extensively searching and retrieving clinical and non-clinical studies for CTD Module 4 and Module 5, writing Module 2 clinical and non-clinical summaries and reviews) • Write literature reviews on clinical or pre-clinical studies, expert reports, substantiation reports, clinical evaluation reports and investigators brochures • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies • Compile maintain regulatory documentation databases or systems according to the requirements different countries (CIS countries, Latin America, European Union, Asian, GCC and the African countries) • Interpret regulatory rules or rule changes as well as ensure that they are communicated through corporate policies procedures • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and also clarity of presentation • Coordinate, prepare, or review regulatory submissions for domestic or international projects

Knowledge

LinkedIn Assessment :
pharmacologyMedical writingRegulatory Documentationnon-clinical studyingPharmaceutical IndustryResearchLife Sciencesregulatory writing

Education

  • PhD in pharmacology science in clinical pharmasist from NATIONAL UNIVERSITY OF PHARMACY in 2010

Training and Certification

  • EU Medical Device regulatory Affairs Certificate Certification
  • Internal Auditor Training Course (based ISO 9001:2015 and ISO 90011:2011 Standarts) Certification
  • Quality system for Medical Device (according to ISO 13485:2003) Certification
  • Risk Management Basics Certificate Certification

Area / Region

Ukraine

Others

Driving License
  • Yes