• Aug 2017 - Present

• Development of the regulatory strategies aimed at achieving marketing authorization and appropriate product labeling to meet company goals and objectives;• Managing the development of strategic plans and tactical implementation for the creation and submission of regulatory documents;• Hiring and building a team of regulatory professionals. Team organization, administration & management (10 staff);• Supervising, mentoring, motivation and development of staff;• Establishment of standard operating procedures for regulatory submissions;• Overseeing and managing regulatory activities, meetings with Health Authorities & consultants;• Driving decision-making regarding complex regulatory and CMC issues;• Building and development of internal and external client relationships and cross-functional collaborations, as well as identifying and sourcing new opportunities with existing or potential clients;• Participating in corporate initiatives and actions that ensure the continued success of the company;• Education of the company staff on regulatory requirements and trends and promoting a regulatory intelligence relevant to the business. Show less

• Sep 2013 - Aug 2017

• Full support of regulatory projects for the EU region from the idea to implementation (planning, budgeting, control);• Building of cross-functional collaboration and communication between the internal divisions of corporation and different production sites in EU and Ukraine;• Expert evaluation of projects from the EU legislation view;• Compilation and preparation of the dossiers required for the medical device/drugs/ supplements registration;• Active participation (as a member) in corporation projects;• Training, supervising & mentoring of new staff.• Sourcing contractors, carrying out negotiations, conclusions of the contracts for regulatory services provision in accordance with the company's goals;• Management of international registration projects (Cosmetics, Medical Devices); • Continuous improvement of the service efficiency, cost optimization and customer satisfaction;• Registration of drugs, medical devices, cosmetics in ASEAN countries (Vietnam, the Philippines, Thailand, Taiwan, Malaysia) and CIS Member States;•Forming of the registration dossier according to the requirements of the countries;•Monitoring, support and control of the registration process; •Preliminary expertise of Module 3;•Development of labeling, based on the requirements of the countries. Show less

Supply & Logistics Specialist

• Jun 2012 - Sep 2013

Supply Manager

• Nov 2011 - Jun 2012

Quality Assurance Specialist

• Oct 2007 - Nov 2011