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42 года, женщина

Москва

Гражданство: Россия

Желаемая должность и зарплата
менеджер по регистрации
100 000 руб.
График, место работы
Полный рабочий день. Ищу работу в городе: Москва . Командировки возможны.
Стаж в желаемой должности
4 года
Профессиональные навыки
Strong chemical and pharmacological background
GCP certificate
Knowledge in biological active proteins
Like to work with people
Fluent English including translation of technical documentations.
Основное образование
Высшее , Oregon Health Science University (OHSU), OR, USA , 2000
 
Опыт работы

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.

 
Основное образование
2000 г.в.

Докторантура

Oregon Health Science University (OHSU), OR, USA

molecular pharmacology
 
1999 г.в.

Высшее образование (магистр)

Bowling Green State University (BGSU), OH, USA

molecular pharmacology
 
1997 г.в.

Высшее образование (специалист)

D. Mendeleyev University of Chemical Technology of Russia,

Environmental engeneering
 
Дополнительное образование

2006 г.в.

Курсы, повышение квалификации

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

 
Подробнее о себе

Семейное положение

Не замужем , Детей нет

О себе

Recommendations are available upon request.
Driving license‚ cat. B.
Advanced PC user.