Leading regulatory projects for the new registration and lifecycle management for ATMP and small molecule products. Product owner in the local project related to simplification initiatives, working in Scrum/Agile methodology. Active participation in legislation review / drafts of the legal acts preparation in the area of drug products registration.

Performing scope of regulatory activities for ATMP and small molecule products in the area of responsibility

Work on products transition to EAEU, engaging cross-functional stakeholders to contribute to smooth products transition to EAEU. Facilitating of the initial registration project. Managing regulatory activities in CIS countries. Close collaboration with cross-functional regional & local team to ensure continuous products supply to the markets in the area of responsibility, participation in the project of supply process simplification. Participation in AIPM working groups related to EAEU, driving legislation updates.

Building regulatory strategy for national and EAEU submissions, primary registration via national and EAEU procedures, life cycle management: CMC and safety updates. Organization of incoming control for primary registered products, regulatory support for serialization activities in Russia

Working with HIV and Multiple Sclerosis portfolio in Russia. Submission of the changes to the registration dossier, both safety and CMC. Preparation of the dossier for the new submissions and recognition via EAEU and national procedure. Leading regulatory activities related to serialization project. Participation in mock-ups preparation. Cross-functional cooperation with supply chain, medical and marketing departments. Full regulatory compliance both in local legislation and company’s procedures.