 Over all in charge for Regulatory submission across CIS region (Mainly Russia, Belarus, Ukraine, Kazakhstan, Kyrgyzstan, Uzbekistan, Moldova…etc)  Over all in charge for Technology Transfer of products from Indian mfg. facility to Russian mfg. facility (local company)  Back end support to Marketing team in tender participation, good relationship with customers, commercial order supply  Back end support to marketing team in identifying new products, understanding patent status, market volume and registering the products  Responsible for submission and getting approval of Russian GMP with close coordination with Russian auditors  Submission of variations and Re-Registrations  Price registration of the Registered Products  Close monitoring and implementation of the procedure of Pharmacovigilance  Close monitoring of BE studies in order to have smooth registrations  Elimination of gaps in communication between main stakeholders: RA HQ, local RA, local QA, local Production; Control and coordination of timelines and each step of dossier preparation locally and globally as well

 Joined as Regulatory Affairs Officer in April – 2009 and worked till December – 2012  Worked for the countries like Russia and CIS, South Africa, Domestic (India), Vietnam  Preparation of dossier for registration of medical products, re-registration, variations.  Request and review of documents required for preparation dossier from the manufacturer  Translation of dossiers to Russian language in support of dossier submissions  Submission of registration dossier to Regulatory Authorities  receiving requests from Regulatory Authorities, preparation of replies on requests and submission it to Regulatory Authorities  Preparation of Normative Documents, Instructions for medical use, correction of package design.  getting Import Permission for samples of medical products, active substances, reference standards for procedure of registration, re-registration, introduction of changes monitoring of procedure of import necessary samples, support of customs clearance  preparation of documentation and samples for Pharmaceutical Expertise, submission them to Regulatory Authorities  Monitoring of Russian registration rules  Implementation of the procedure of Pharmacovigilance  Preparation of plans of registration, re-registration, introduction of changes monitoring of procedure clinical trials of medical products

Joined as Officer in production department in July-2007 and worked till Jan-2009 Worked in Animal vaccine production department