Experience

CRATIA LTD.

• United Kingdom
• Consumer Services
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Aug 2022 - Present



JSC BIOCAD, Kyiv

• Kyiv City, Ukraine

• Regulatory Documentation Specialist in the medicines development and registration field

  • Nov 2015 - Feb 2022

  Preparation of a registration dossier in the CTD format (Module 3) for different types of registration procedures (initial registration, changes to the registration dossier, obtaining a permit to conduct a clinical trial, etc.) and regions (EU, Ukraine, EAEU). Quality assurance of the registration dossier documentation in accordance with the ICH and EMA guidelines. Adapted translation of Drug Master File \ Active Substance Master File from English into Russian and Ukrainian. Management of the drug registration process. Preparation of the project plan, coordination of project terms and risk assessment for its implementation. Support for quality management system (QMS). Show less



Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines

• Kharkiv, Ukraine

• Research Fellow

  • Oct 2005 - Sep 2015

  Documentation evaluation and development in the field of medicines quality control (standardization). Registration dossier evaluation in the CTD format (Module 3). Validation of analytical methods of quality control and testing in accordance with the State Pharmacopoeia of Ukraine (SPhU) requirements, development of supporting documentation in accordance with modern standards (international documents ICH / EMEA, WHO and FDA requirements). Certification and commissioning of standard pharmacopoeias samples of the SPhU. Show less