Preparation and execution optimal regulatory strategies aimed to deliver product approvals and life cycle management in accordance with the regulatory objectives of the regional business.

Develop effective relationships and effective liaison with local commercial organization, distributors and service providers.

Provide regulatory guidance and advice on local country regulatory environments;

Provide assessment of the impact of new and changing regulations/requirements in Ukraine.

Ensure compliance of regulatory activities with Country laws and company internal protocols and procedures.

Budget planning.

1 person is under my subordination.

Preparation and execution optimal regulatory strategies aimed to deliver product approvals and life cycle management in accordance with the regulatory objectives of the regional business.

Act as a leadership team member in brand planning and business cases approval process.

Develop effective relationships with local commercial organization, distributors and service providers in applicable 10 CIS countries.

Provide effective liaison with the regulatory agencies in the region directly, through distributors contacts and service providers.

Provide regulatory guidance and advice on local country regulatory environments;

Provide assessment of the impact of new and changing regulations/requirements in CIS countries.

Ensure compliance of regulatory activities in CIS countries consistent with Country laws and company internal protocols and procedures.

Budget planning. Sources allocation.

3 persons are under my subordination.

New Marketing Authorization approval procedures for original products in Ukraine and other 11 CIS countries (Belarus, Moldova, Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Turkmenistan, Uzbekistan, and Tajikistan).

Regulatory strategy development for line extension of existing products portfolio. CMC and Labeling variations management for life-cycle of the products. Renewal procedures management. GMP recognition management. Quality and compliance management for RX products life-cycle.

Regulatory support in promotional materials development for new products and existing portfolio. Regulatory planning and monthly reports preparation.

Participate in meetings of EBA, AIPM, ACC and meetings with SEC about issue of harmonization of Legislation of Regulation Affairs between legislation in UA and EU countries for MP, FS, C according to EU Directives/Regulations/Guidelines.

2 persons were under my subordination.

New registrations, Renewals and variations to approved registration dossiers for Medicinal Products (MP), Food Supplements (FS) and Cosmetics (C).

Establish and maintain contacts with regulatory bodies, registrations agencies, expertise institutions and opinion leaders in the field of registration by open and transparent manner. Negotiate and communicate with HA all issues related to regulatory procedures. Ensure that all local procedures comply with global directives and procedure, as described in the procedure on review and implementation of global directives.

Coordinate registration issues as well as labelling compliance in local country proactively.

Contact HA on drug safety matters: PV, PSURs submission

Obtain approvals in line with registration plan.

Timely implementation of approved labeling and CMC changes into the packaging materials according to SOP and the local requirements. Provide change management: dossier timely, in good quality and properly documented submission and approval of variations.

Relevant regulatory processes by SOPs updating.

Monitoring of the local legislation and competitive environment changes, promoting awareness of regulatory requirements and registration status changes within the company, influencing legal landscape via local networking.

Contributing to the development of strategies that meet both regulatory and commercial objectives, contributing to the successful products' launches.

Participate in meetings of EBA, AIPM, ACC and meetings with SEC about issue of harmonization of Legislation of Regulation Affairs between legislation in UA and EU countries for MP, FS, C according to EU Directives/Regulations/Guidelines.

Manage of RA Specialist for different status products and type of procedures.

New registrations, Renewals and variations to approved registration dossiers for Medicinal Products (MP), Food Supplements (FS) and Cosmetics (C).

Establish and maintain contacts with regulatory bodies, registrations agencies, expertise institutions and opinion leaders in the field of registration by open and transparent manner.

Negotiate and communicate with HA all issues related to regulatory procedures.

Coordinate registration process for different companies (Pfizer, Gilead, Amgen, BMS, Mentholatum).

Designing and carrying out the experiments to study DNA damage in normal and tumor cells using DNA Comet Assay after influence of nitric oxides and low doses of ionization radiation, using statistical programs for data analysis.

Preparation of scientific reports and publications, presentation of data on regular seminars and scientific meetings.

Biotechnological outgoing quality control of Medical devices such as ELISA and PCR kits.

Recombinant protein construction and purification by chromatography.