Denys Nalbat

• Regulatory database maintenance. Including creation and monitoring of Periodic Safety Report (PSURs), Risk Management Plan (RMPs), RA, MA, Commitments and Change Control records. • Metrics and trackers creation and monitoring for global and regional functions. • Visualization of regulatory data by more than 30 Dashboards using Power BI. • Audits support with data supply. • Trained 100+ people in regards to the procedures and system use.

• Implemented Validated GxP system into PV, RA, CMC and QA activities with ad hoc, 24/7, live reports and dashboards. • Created SOPs and procedures for PV (RMPs, PSURs, etc.) and other functions data and documents management in systems, including version control, lifecycle activities, etc. • Perform monthly verification of information in systems to ensure accuracy. • Compilation of dossiers in collaboration with diverse stakeholders into different formats for EEU, EMEA , RoW • Documentation quality control.

- Conducting of full process for new registration/renewal/variation procedures. - Communication with National Competent Authority; manufacturers; business partners, cross-functional divisions. - Monitoring changes in legislation, identifying risks/opportunities and driving business protection project addressing recent changes. - Preparation of documentation dossiers. - Maintaining of Artwork, labeling and samples process (preparation/correction/proofreading/approval of packaging components).