- Cooperation with manufacturing sites (business correspondence, regulatory strategy, timely informing etc.). - Request and the receipt of all required documents for the registration dossiers from Regional Offices to make provision of the uninterrupted active registration status of the portfolio of about 68 products for all kind of procedures – Marketing authorizations, renewals and variations. - Documents assessment in ENG versions and discrepancies elimination in contact with the manufacturer’s QA, QC and RA departments and coordination the documents obtaining for its submission on time. - Documents selection for the translation. - Setting up the Dossier as per local requirements with appropriate translations for submission (administrative part, chemical and pharmaceutical; pre-clinical and clinical parts) for the New Registration/Renewals/Variations procedures. - Control and maintenance of all registration process timelines (PR creation, obtaining of the Primary/Specialized Agreements and management of its payment, timely LHA answers providing, close communication with LHA (and appropriate departments of it) - Order/receive samples and reference standards for the registration purposes on time for submission and receipt the MoH permission letters for the import of these standards. - Ensure product registration is completed on time to support NPI timelines. LABELING & PACKAGING ACTIVITIES - PACKAGE INSERT - Ensure package insert is routed to Medical/PV Department for approval before the submission. - Order new artworks and follow up approvals. - Follow up MoH approval process and give approval for implementation of new artworks on time according to plan. - Ensure regulatory compliance in preparation, review and approval of artworks development for marketed products in Belarus. NEW PRODUCT LAUNCHES - Actively participate in new product task forces and support Sales & Marketing Divisions for new products launches in Belarus. OTHER CROSSFUNCTIONAL ACTIVITIES - Organization and support, participation in conducting inspections of a production site for compliance with GMP requirements (obtaining visas, planning a transfer and a schedule of audits, assisting the manufacturer in warning and making comments, in preparing a CAPA). - Functions of a contact person for pharmacovigilance, signal reception and transmission. - Certification of products delivered to the market (control, verification, preparation of translations and provision of certificates of analysis to clients) for approval for sale in pharmacy chains. - Timely and correct entry of data on the regulatory status of products in the global system. - Ensuring compliance with industry codes of conduct, advertising codes, various laws and regulations applicable to the role, as well as a program of law-abiding behavior in the company, knowledge of corporate policies, business ethics, working in strict compliance with the requirements of compliance.

- Food supplements of foreign manufacture artworks analysis; development of the marking texts as per EAEU requirements; - Medical device BY marketing authorization. Assistance during the procedures of the dossier expert evaluation in regulatory body and samples quality control in certified laboratory. Marketing authorization Certificate obtaining; - Development of the Quality Management System (the set of Standard Operational Procedures) for the pharmaceutical warehouse as per GDP requirements.

(1 год 5 месяцев) Regulatory Affairs Manager * Business correspondence with foreign manufacturers; * Revision of the registration dossiers for the medicinal products completeness and correctness. Work in contact with the manufacturer to correct and complete the dossier documentation. Development of normative document for product quality control as per Belarussian regulatory requirements on the basis of the manufacturers analytical procedures. Dossiers issuance and submission. Work in contact with the Belarussian regulatory authorities on the elimination of experts queries and finalization of registration procedures; * Translation of manufacturers documentation (English- Russian, Russian - English); * Preparation and submission of variations, work in contact with the regulatory authorities on the elimination of experts queries and finalization of registration procedures; * Regulatory requirements proficiency (ГФ РБ, Laws, Resolutions, Desisions, TCP, Guidelines etc.); * Work in contact with the MoH Quality control laboratories, acting in methods of analysis approbation as per normative document for product quality control; * Samples and standards, HPLC columns dispatches organization and control of dispatches. MoH permits obtaining; * GMP inspection of manufacturing site organization and accompanying of inspection team, support in possible queries prevention, support in inspection queries elimination. 1 successfully finalized inspection with no even non-significant objections.

• Marketing authorizatio of food supplements and sports nutrition of foreign manufacture in the territory of the Customs Union; • Analysis of documentation on the products composition and characteristics, drawing up of conclusions on the possibility of products registration of proposed compositions on the territory of the Customs Union; • Translations (English ⇄ Russian) of the manufacturer's documentation; • Preparation of label texts for product labeling in accordance with the requirements of the Customs Union; • Maintenance of the procedure of sanitary and hygienic testings, interaction with republican laboratories, test reports and conclusions on the productsconformity obtaining; • Conclusions of the Ministry of sports and tourism on the possibility of using products in sports practice obtaining; • Maintenance of the marketing authorization procedure, the Certificates of marketing authorization of food supplements, sports nutrition of foreign production obtaining; • Variations procedures maintenance in the obtained Certificates of marketing authorization.

(2 года 2 месяца) * Business correspondence with foreign manufacturers; * Revision of the registration dossiers for the medicinal products and food supplements completeness and correctness. Work in contact with the manufacturer to correct and complete the dossier documentation. Development of normative document for product quality control as per Belarussian regulatory requirements on the basis of the manufacturers analytical procedures. Dossiers issuance and submission. Work in contact with the Belarussian regulatory authorities on the elimination of experts queries and finalization of registration procedures; * Translation of manufacturers documentation (English- Russian, Russian - English); * Preparation and submission of variations, work in contact with the regulatory authorities on the elimination of experts queries and finalization of registration procedures; * Regulatory requirements proficiency; * Work in contact with the MoH Quality control laboratories, acting in analysis approbation as per normative document for product quality control; * Dossier for food supplements evaluation for the compliance of EurAsEC regulatory requirements. * Work experience with the dossiers for antibiotics, cytostatics, antiretroviral products. * GMP inspection of manufacturing site organization and accompanying of inspection team, support in inspection queries elimination. 2 successfully finalized inspections (antibiotics, cytistatics sterile medicinal forms).

(1 месяц) RUE Belmedpreparaty for Standardization and Certification * Preparations and execution of registration dossiers for foreign manufactured medicinal products, maintenance of documentation during registration procedures in cooperation with Ministry of Health authiloritiesof the Republic of Belarus, translations of specialized documentation from /into English, correspondence with a foreign manufacturers.

(1 год 2 месяца) Development and managing of the technological documentation and manufacturing records (BMR); in-process quality controlof semiproducrs (bulk); managing of inventory reports; planning and implementation of innovative, experimental manufacturing processes etc.

Organic Substances Technology Faculty, Biotechnologist

УП "Центр экспертиз и испытаний в здравоохранении"

ООО "ЮрСпектр"

Группа компаний "Виалек"