 Leading of RA activities and submission strategy for Russia/EAEU including different types of variations (including CCDS and CMC updates) submissions, EAEU harmonization and MAA submissions  Project and People management  Roadmap writing and GAP assessment performing  Due diligence  Authoring/ writing of local ND, PIL, SmPC, readability user testing and AW in accordance with global/ local/ EAEU requirements as well as short PIL for sales force department  Publishing dossiers via EAEU and national RU regulations  Provision technical knowledge and support and updates of regulatory requirements to global and local team  Proper maintenance of numerous global and local electronical environments (dedicated to RA, PV, CT activities as well as personal time management activities and KPI)  Regulatory Intelligence tasks (close monitoring of EU/ EAEU/ Russian regulatory/PV/CT and serialization requirements and updates)  Close collaboration and support of GRA as well as global and local teams: PV, CT, QA and Commercial  Performing monthly reports to General Manager and Commercial director as well as to global team  AW coordination creation, proof-reading and signing for production in line with corporate SOP  Promotional and non-promotional materials reviewing and approval  Samples and reference standards ordering in line with corporate SOP and local import permission receiving  Budget planning and its control; invoice payment coordination  Managing of serialization project/ Track&Trace with support of GS1 and MDLP

 Project management (including different types of variations submission, EAEU conversion and new MAA submission) in line with EAEU/ Russian regulation  Provision technical knowledge and support of regulatory requirements to global and local team for specific projects  Proper tracking different global and local databases (dedicated to RA, PV, CT activities)  Regulatory Intelligence performing (close monitoring of EU/ EAEU/ Russian regulatory requirements and updates)

 People management: managing sub team (2 employees). Regulatory product life cycle management (variations submissions and approval including new indications, new manufacturing sites)  Preparation of local SOP, ND, PIL and AW in accordance with global/ local/ EAEU requirements and regulation with further implementation  Cross functional close collaboration on daily basis with QA, Logistics and Marketing Departments to be in line with corporate strategy and deadline  Supporting in developing and execution RA strategy for Russia/EAEU, coordination and monitoring activities of the sub team to align with global and local vision  Performing and coordination of sample purchase, columns, ref. standards orders and its shipment to be in time with established RA strategy. In close collaboration with RA, Logistics and HQ  Budget planning and its control  Performing Rx/OTC switch and submission RA plan of assigned product pool  Proper tracking global and local databases  Direct and close cooperation with GRA: providing reports, TConferences  Reviewing and approval of promo materials  Supporting in preparation legal administrative documents (PoA, official letters, statements and etc)

 New products registration. Regulatory product life cycle management (variations submissions and approvals). Tracking of variations in regulatory database. Responsible for 60 products (to be localized for full cycle/ packaging at Moscow manufacturing site)  Organization and control of Department’s activities  Managing of RA team (5 persons) and PV manager  Performing Department’s KPI  Direct reporting to General Director of the Company and to HQ  Transfer process implementation: close communication and collaboration with HQ (India), Moscow office, manufacturing site (QA, Logistics and Production Departments)  Performing RA strategy in line with marketing vision, coordination activities of RA Department and CROs (including clinical studies part)  Control of samples, columns, ref.standards purchase orders and its shipment & custom clearance to be in time with established RA strategy. In close collaboration with RA, Logistics and HQ  Budget planning for transfer activities. Communication with Financial Department regards to price registration for Company portfolio  Service Agreements preparation between Company and Vendors, and further control and monitoring  Implementation and administration of the Tracking System dedicated to Transfer process (localization) and samples, standards purchase  Separate project – creation of Technology Transfer System and its integration into Company’s work environment on daily basis locally and globally  Development of SOP, Working Instructions and other Department’s documents  Performing presentations (including RA status of FP and API for HQ visits)

 Cross-functional collaboration on daily basis with Marketing Department, Business Development and Supply Chain to be in line with all agreed deadlines  Supporting in marketing analysis, development marketing strategy, identifying appropriate indications of drug product dedicated to Women’s & Men’s Health (Utrogestan, Progestogel, Lactogynal, Androgel). Participate in creation of promo materials for CEE region  Identification and execution of RA strategy for the Region to align to Global vision as well as local  Selection of third-party local companies supported in RA activities and Market Access  Preparation of drafts of Service Agreements, PoAs, and internal SOP  Managing CEE agents with regards to pricing and reimbursement activities, RA submissions of Rx product and dietary supplement  Planning, monitoring RA submissions and approvals in CEE and CIS  Supporting in provision all documentation for RA submissions, notifications as well as price registrations  Tracking and update RA corporate database  Reporting to Regional Head on monthly basis  Participation in PV activities in the Region, identify execute the terms and conditions of the outsourcing company, monitoring its activity to be in line with policies of Global PV  Development and implementation of SOPs, Work Instructions. Contribution into CAPA plan. Assurance of preparation for external audits and HA Inspections. Management of product complaints, timely reporting

 Preparation dossiers (via FirstDoc and e-CTD manager), tracking daily activities with HQ and agent/affiliate. Close communication with GRO  Order reference standards and samples for QC testing/ re-testing. Close collaboration with RegSamples department, having full access to kit database Daily collaboration with CIS Director, checking Forecasts, Orders from vendors  Strong collaboration with Supply chain and Moscow logistic department to be in line with estimated timelines of a product’s launch, comprehension of JDA system, SKU. Preparation forecasts  Review and approval of promo materials for registered product for Women’s health (Gonal-f) and others therapeutic areas (Neurology, Endocrinology)  Review and fulfil a Compliance Sheets as well as Labelling CS. Track and monitor activities in the Dashboard. Use SPT system  Close interaction and communication with local agents (vendors) in CIS and Russia with the view of providing of all relevant information (ordering dossier in accordance with local requirements for each country, ordering standards and samples in sufficient and corresponding quantities for performing QC testing, make request for preparation administrative document - CPP, GMP, ML)  Workshop preparation for vendors regarding e-Tools to be used daily in communication with HQ, Moscow office  Prepare a draft of PoA (in accordance with the content of a service agreements) as well as amend it accordingly to Global Legal department  Making support in selection third party, vendors  Prepare, make appraisal and finally agree a budget on registration activity for each of the CIS countries with split it up in accordance to BU, Financial Department requests to be in line with targets and KPIs  Participate of preparation Service agreement and Annexes for registration activity in CIS  Prepare local SOPs in accordance with local legislation and requirements (artwork development, interaction between Global, local RA and third parties)  Directly and close collaboration with GRA; directly reporting to Medical Director as well as to HQ, providing in large reports; arrange monthly TC; consideration current issues in registration activity, planned registration/renewal/variation in accordance with local regulatory requirements specific for each country  Directly and close collaboration with GRA; directly reporting to Medical Director as well as to HQ, providing in large reports; arrange monthly TC; consideration current issues in registration activity, planned registration/renewal/variation in accordance with local regulatory requirements specific for each country

 Preparation dossiers (via FirstDoc and e-CTD manager), indicate sending date from HQ to agent/affiliate. Close communication with GRO  Ordering reference standards and samples for QC testing/ re-testing. Close collaboration with RegSamples department. Full access to kit database  Full packaging activity with excellent knowledge of labelling requirements per country: make request in system (TrackWise, D2), coordination and harmonization with local agents (vendors) text of leaflet, box and label; signing the artworks and approve implementation date; recording and keep reports in the system  Keeping reports in electronic and written forms (creation files, achieve full correspondence for each country), monthly reporting directly to HQ  Close interaction and communication with local agents (vendors) in CIS and Russia with the view of providing of all relevant information (ordering dossier in accordance with local requirements for each country, ordering standards and samples in sufficient and corresponding quantities for performing QC testing, make request for preparation administrative document - CPP, GMP, ML)  Strong collaboration with Supply chain and Moscow logistic department to be in line with estimated timelines of a product’s launch, comprehension of JDA system, SKU. Preparation forecasts  Preparation drafts of PoA and administrative documents (in accordance with the content of a service agreements) as well as amend it accordingly to Global Legal department  Making support in selection third party, vendors  Preparing, making appraisal and finally agree a budget on registration activity for each of the CIS countries with split it up in accordance to BU, Financial Department requests to be in line with targets and KPIs  Participation of preparation Service agreement and Annexes for registration activity in CIS  Preparation local SOPs in accordance with local legislation and requirements (artwork development, interaction between Global, local RA and third parties)  Reviewing and fulfilling a Compliance Sheets as well as Labelling CS. Track and monitor activities in the Dashboard. Use SPT system  Directly and close collaboration with GRA; directly reporting to Medical Director as well as to HQ, providing in large reports; arrange monthly TC; consideration current issues in registration activity, planned registration/renewal/variation in accordance with local regulatory requirements specific for each country

 Preparation and complete dossiers and relevant documentation in accordance with local registration requirements of HA  Preparation variations into ND/PIL in accordance with local requirements of expertise centers in CIS and Russia  Submission dossiers and relevant documents to the Centre of Expertise and maintenance procedure of registration  Obtaining Registration Certificate and relevant registration documentation, preparation in accordance with SOP Compliance Sheet, scanning and providing documentation to HQ  Supporting packaging activity in accordance with local requirements on labelling: make request in system, coordination and harmonization with local agents (vendors) text of leaflet, box and label; signing the artworks and approve implementation date; recording and keeping reports in the system  Preparation documents for pharmaceutical expertise in FGU (for Russia)  Preparation documentation files for registration prices, bar-codes, carrying out preliminary and random control; receiving permission on release product (in Russia)  Preparation documents on variations into ND/PIL in accordance with local requirements of expertise centers in Russia  Keeping and achieve documents of registrations and renewals in electronic and written forms  Maintenance finance reports (receiving invoices, closing acts, agreements with responsible centers in charge of regulatory issues)  Close communication with HQ (Belgium) and coordination registration procedures with local agents in CIS  Acquaintance with CIS Pharmacopoeias for further using knowledge in creation and preparation dossiers in accordance with local requirements for CIS

Sales activity of Rx and OTC brands