2007, июль — 2007, октябрь, 3 мес
Head of Regulatory and QC department
Ferrosan International A/S
-Coordination of registration/renewal of the medicines, food supplements, cosmetics
-Coordination of the registration in CIS countries
-Certification of the food supplements
-Certification support and support of logistics
-Quality control Issues, co-operation with plant
-Package marking, cooperation with marketing
-Regulation of legal issues during registration/renewal, connection with Authorities, AIPM
-Negotiations with State Regulatory Institutions, Tarasevich Institute.
2007, май — 2007, июль, 2 мес
Head of Regulatory Department
Shreya Lifesciences
-Coordination of registration/renewal of the medicines
-Coordination of the registration in CIS countries
-Certification of the food supplements
-Certification support and support of logistics
-Quality control Issues, co-operation with plant
-Package marking, cooperation with marketing
2004, август — 2007, март, 2 года 7 мес
registration specialist
Pfizer International LLC
-preparation of the technical dossiers (RS, Methods of analysis) in Russian for new products, working out of strategy for new product development including medicines (Rx and OTC), medical devises and cosmetics;
-arrangement of all renewals and variations in accordance with marketing strategy;
-regulatory support of registration in the former CIS countries;
-negotiations with the Pharmacopoeian and Pharmacological Committees, GOST R; and other State Regulatory Institutions;
-cooperation with Marketing, Logistics and Finance departments;
-elaboration of the Russian versions of package marking;
-contacts with the design agencies and plants;
-certification support;
-participating in quality complains investigations;
-data bases support
2002, ноябрь — 2004, август, 1 год 9 мес
registration manager
ALSI Pharma
-responsible for analysis and preparation of registration package to the MoH;
-working out strategies for registration and developing of new drugs;
-keep contacts with all structures of MoH, licensing agency;
-preparation of the documents for clinical research;
-responsible for patent examination of all products planning for registration;
-work with research institutes.
Докторантура
Oregon Health Science University (OHSU), OR, USA
Высшее образование (магистр)
Bowling Green State University (BGSU), OH, USA
Высшее образование (специалист)
D. Mendeleyev University of Chemical Technology of Russia,
2006 г.в.
Center of pharmaceuticals study, Moscow
GCP training, Certificate
2004 г.в.
Moscow (MoH)/Russia
Seminar: Practical problems of drugs expertise, Certificate
2004 г.в.
Moscow Institute of biophysics and biochemistry/ Russia
Population pharmacokinetics/pharmacodynamics. Individual pharmacotherapy, Diploma
Семейное положение
Не замужем , Детей нет
О себе
Recommendations are available upon request.<br />Driving license‚ cat. B.<br />Advanced PC user.
id резюме: 6057411,
обновлено 24-01-2008 13:58:59