Being educated in pharmaceutical field and working as a Regulatory Consultant, I'm interested in any co-operation in such regulatory areas as preparation of new submissions, renewals and variations worldwide (special interest in Russian-speaking zone), update of drug product labelling, as well as scientific translations for regulatory purposes. Specialties: Good knowledge of Russian professional language and regulatory particularities of CIS countries, work experience in multinational & multicultural environment. Knowledge of global regulations, regulatory experience in different areas of the World.
Senior Regulatory Consultant
Since May 2015
Consultancy in dossier compilation for: EU, USA, Emerging markets, Rest of the World. Product lifecycle: new submissions, renewals, variation procedures. Worldwide labelling update. Scientific translation: Russian, Hungarian, English, French
Head of CIS RA Department
July 2013 --- May 2015
CIS RA department I led was responsible for registration of medicinal products in CIS counrties, including preparation of dossiers for CTA in Russia, manufacture localisation to Russia, and both new applications and maintenance activities for a large portfolio of approximately 1500 MAs in all the CIS countries, in close collaboration with Marketing and Sales departments.
Senior RA Consultant, Head of Regulatory Affairs/Regulatory Operations
July 2012 --- July 2013
Leading of the team of regulatory affairs/ regulatory operations specialists at ProductLife BVBA, providing consultance services to Pharma companies in Benelux & Skandinavia. Regulatory maintenance of Active Pharmaceutical ingredients at Janssen Pharmaceutica NV, Belgium. Advisory work connected to regulatory affairs in CIS countries.
October 2006 --- June 2012
Regulatory maintenance and territory extension activity for designated products in CIS countries. Professional lead in Regulatory Databank work. Leadership of a team in charge of update of Company's registration database and of management of regulatory maintenance for product series in terms of CMC.
January 2004 --- September 2006
Preparation of regulatory documentation according to country-specific requirements for CIS countries
September 1994 --- December 2003
Translation of registration documentation for MAA submissions in CIS countries, as well as of technical documents needed for manufacturing sites
December 1990 --- March 1992
pharmaceutical professional in a pharmacy
September 1985 --- November 1990
Research of new antitumor antibiotics
Skills and Expertise
Regulatory requirementsDevelop regulatory strategyPrepare regulatory documentsRegulatory submissionsLate-stage regulatory filing (MAA, BLA)Generate regulatory submissions Manage projects resources Create SOPs Interpret data Write papers regulatory databases
candidate of Biological science in Biology, chemistry, biotechnology from Academy of Medical Science in 1990
Master of science in Pharmacy from Semmelweis Medical University in 1985
Master of Science in Pharmacy from First Moscow State Medical University named after I.M. Sechenov in 1985