(Responsibility for Armenia, Azerbaijan, Georgia, Uzbekistan, Kyrgyzstan, Turkmenistan, Tajikistan and Mongolia until April 2018) • Providing local regulatory strategy, guidance and leadership to the local Regulatory Affairs (RA) team in Kazakhstan, Armenia, Azerbaijan, Georgia, Uzbekistan, Kyrgyzstan, Turkmenistan, Tajikistan and Mongolia. • Developing and aligning of local registration strategy with regional RA and local business • Establishment of Cross-functional EAEU team in KZ for closely monitoring legislations/regulations and incorporation into local strategy, presentation of KZ in monthly EAEU related meeting with RCV and GRA • Support Portfolio initiatives according RCV Human Business Pharma strategy • Continue to support the Portfolio management process focused on unused registrations and divestments • Accountability for local CAPA actions, including pro-active and timely communications • Support all RCV RA Quality Plan 2019 identified actions and strive to timely closure • Tracking, communication and impact assessment of new local regulatory requirements via established RIN process • Arrangement of Manufacturing Site visit for KZ HA • Preparation of the dossier for new registration/renewal and variations in Kazakhstan, Armenia, Azerbaijan, Georgia, Mongolia, Kyrgyzstan, Turkmenistan and Uzbekistan • Writing of patient information leaflets and tracking the PIL review and approval process by Medical advisor, Product Manager and Medical Director • RMP, PSUR and Educational materials submission to local HA in accordance with local submission schedule, appropriate tracking of submission • Creation of Manuscript for the local Art Works, reviewing and approval of created AWs • Regular communication with Supply Chain and Marketing departments, with RCV and Global RA regarding the RA activity/status • Regular updating of Corporate Product Database for allocated products • Reviewing of promotional materials with the locally approved patient information leaflet (PIL) and ensure compliance with the local and global regulatory framework • Quality check of CIOMS translation • Local review of domestic individual case safety reports (ICSRs) in PV System In case of deputizing of Local Product Complaint Officer (LPCO), performing the following activities (LPCO responsibility till November 2018): • Handling of complaints, recording of complaints in the complaint management system, closure of complaints / communication of results to the complainant, handling of recalls, ensuring/performing communication to authorities In case of deputizing of Local Pharmacovigilance Manager, performing the following activities: • Management of Adverse Events (evaluating cases for validity and consistency, documenting cases according to procedures, assessing case severity in order to prioritize follow-up, reviewing data against source documents, submitting data in a timely manner, properly assessing submission eligibility on a case-by-case basis as per the regulations, reviewing and documenting regulatory agency requests, preparing responses based on requests, filing case reports according to archiving practices). • Collection, processing (IRT&OST), reporting of domestic individual case safety reports (ICSRs), including literature cases, to the KZ&CIS HAs. • Collection, processing (IRT&OST), FU, reporting of domestic ICSRs of the ongoing NTA to the KZ HA • Reporting foreign ICSRs (OST module, manual submission) to the KZ & CIS HAs. • Submission of CIOMS of the domestic ICSR along with the local AER Form to the KZ HA. • Daily screening of the KZ and KG HAs websites for identification of ICSRs and documenting the check and results of the screening in the tracker. • Screening of local literature within one week after receiving the publications and documenting the check and results of the screening/processing PV relevant information. • Responsibility for the reconciliation processes

Preparation of the dossier for new registration/renewal and variations in Kazakhstan, Armenia, Azerbaijan, Georgia, Mongolia, Kyrgyzstan, Turkmenistan and Uzbekistan • Writing of patient information leaflets on the base of EU SmPC and tracking the PIL review and approval process by Medical Advisor, Product Manager and Medical Director • RMP and PSUR submission to local HA in accordance with local submission schedule, appropriate tracking of submission • Creation of Manuscript for the local Art Works, reviewing and approval of created AWs • Regular communication with Supply Chain and Marketing departments, with RCV and Global RA regarding RA activity/status • Regular updating of Corporate Product Database for allocated products • Communication and impact assessment of new local regulatory requirements • Reviewing of promotional materials with the locally approved patient information leaflet (PIL) and ensure compliance with the local and global regulatory framework In case of deputizing of Local Product Complaint Officer (LPCO), performing the following activities: • Handling of complaints, recording of complaints in the complaint management system, closure of complaints / communication of results to the complainant, handling of recalls, ensuring/performing communication to authorities In case of deputizing of Local Pharmacovigilance Manager, performing the following activities: • Management of Adverse Events (evaluating cases for validity and consistency, documenting cases according to procedures, assessing case severity in order to prioritize follow-up, reviewing data against source documents, submitting data in a timely manner, properly assessing submission eligibility on a case-by-case basis as per the regulations, reviewing and documenting regulatory agency requests, preparing responses based on requests, filing case reports according to archiving practices). • Collection, processing (IRT&OST), reporting of domestic individual case safety reports (ICSRs), including literature cases, to the KZ&CIS HAs. • Collection, processing (IRT&OST), FU, reporting of domestic ICSRs of the ongoing NTA to the KZ HA • Reporting foreign ICSRs (OST module, manual submission) to the KZ & CIS HAs. • Submission of CIOMS of the domestic ICSR along with the local AER Form to the KZ HA. • Daily screening of the KZ and KG HAs websites for identification of ICSRs and documenting the check and results of the screening in the tracker. • Screening of local literature within one week after receiving the publications and documenting the check and results of the screening/processing PV relevant information. • Responsibility for the reconciliation processes

• Monitoring of Regulatory Compliance within Regulatory Department for 11 CIS countries (Kazakhstan, Belarus, Georgia, Azerbaijan, Uzbekistan, Armenia, Mongolia, Kyrgyzstan, Moldova, Tajikistan and Turkmenistan) for Pharma and Onco products • Regular update and maintenance of compliance database for CIS countries (creation of variations, entering of regulatory information, planned/actual submission/approval dates for each product, country folder validation) for Pharma and Onco products • Management and timely resolution of compliance issues at CPO level with local and global cross-functional support • Participation in global Regulatory Compliance Projects as a single point of contact for CIS countries • Escalation of deviations, compliance incidents and potential compliance risks to Global DRA Management and its proper submission and in QA incidents management system • Attendance and active participation in monthly PIE compliance associates meetings • Reviewing of promotional materials with the prescribing information as approved by local regulatory authorities (for 8 CIS countries)

Preparing and submission of the dossier for new registration/renewal and variations for Rx and OTC pharma products, vaccines and other biological products to strict deadlines • Monitoring and setting timelines for license variations; • Creation Analytical Normative Documentation (AND) in accordance with local requirements directly from English Specification and analytical methods • Writing of patient information leaflets on the base of global PI and approval with Medical advisor and Product Manager • Calculation of samples and reference standards required for analytical expertise • Preparing and submission documents for getting of import permission for samples • Reviewing and approval of Russian-Kazakh labelling text for artworks • Working in OPAL database (completion of current and projected regulatory activity) • Maintain an appropriate level of documentation archiving and its proper usage •Close communication with Logistic and Marketing departments about any regulatory activity that can affect on supply (conduction of regular meetings every 2 weeks, preparing a dashboard with step-by-step activity for each product) •Undertaking and managing regulatory site inspections; • PSUR submission for all products in accordance with global submission schedule, appropriate tracking of submission • Reviewing and signing of TTS • Participation in Global project of reviewing of approved documents (PILs, artworks and AND) to the original documents (English version of the dossier, GDS) • Communication with Global regulatory team (TC, e-mails) • Communication with translation agencies and correction of translated documents

• Preparing and submission of the dossier for new registration/renewal and variations for Rx and OTC pharma products • Creation Analytical Normative Documentation (AND) in accordance with local requirements directly from English Specification and analytical methods • Writing of patient information leaflets on the base of global PI • Calculation of samples and reference standards required for analytical expertise • Preparing and submission documents for getting of import permission for samples • Reviewing and approval of Russian-Kazakh labelling text for artworks

• Reviewing of Analytical Normative Documentation and sample analysis reports completed by Analytical Chemists; • Conducting of analysis for drug products during registration, renewal or routine certification; • Water quality analysis; • Performing of routine calibration, maintenance of laboratory equipment • Performing of analytical procedures and testing using gas chromatograph, high performance liquid chromatograph, UV-spectrophotometer, IR- spectrophotometer, densitometer and viscometer.

• Creating of Analytical Normative Documentation and completion of sample analysis reports; • Conducting of analytical analysis of drug products during registration, renewal or routine certification; • Water quality analysis; • Performing of routine calibration, maintenance of laboratory equipment • Performing of analytical procedures and testing using gas chromatograph, high performance liquid chromatograph, UV-spectrophotometer, IR- spectrophotometer, densitometer and viscometer.