Rakant Alla



General information

Rakant Alla



Birthday: 29.04.1974

 
Residential area: Россия, Москва918

 
Language proficiency: English - fluent

 

Autobiography

Я работаю в области Медицина/Фармацевтика
Моя профессия - Health Regulatory Affairs Manager (Registration Manager)

Professional experience

Previous jobs

  • Ferrosan International A/S - Head of Regulatory and QC department (2007-07-01 00:00:00.0 - 2007-10-01 00:00:00.0)

    -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.

  • Pfizer International LLC, Moscow representative office - Health Regulatory Affairs Specialist (2004-08-01 00:00:00.0 - 2007-03-01 00:00:00.0)

    -Preparation of the technical dossiers (RS, Methods of analysis) in Russian for new products, strategy for new product development including medicines, medical devises and cosmetics;
    -arrangement of all renewals and variations in accordance with marketing strategy;
    -negotiations with the Pharmacopoiea and Pharmacological Committee, GOST R; and other State Regulatory Institutions;
    -certification support;
    -elaboration of the Russian versions of package marking;
    -contacts with the design agencies and plants;
    -participating in quality complains investigations;
    -data bases support
    -support of registration in the countries of former Soviet Union.

  • Oregon Health Science University (OHSU), OR, USA - Researcher5 (1999-08-01 00:00:00.0 - 2002-08-01 00:00:00.0)

    Research in the field of membrane proteins, active transport, molecular pharmacology.

  • Bowling Green State University (BGSU), OH, USA - TA, researcher, graduate student (1997-08-01 00:00:00.0 - 1999-07-01 00:00:00.0)

    Research in the field of photobiology at the Center for Photochemical science of BGSU, drug design, nominated with McMaster fellowship.

Education

University education

  • Bowling Green State University, Photochemistry&Photobiology, Certificate of Competence, 1999
  • D. Mendeleyev University of Chemical Technology of Russia, Environmental protection, diploma (5,5 y )1997

Training courses

  • GCP seminar, Center of Pharmaceuticals Studies, GCP certificate, 2006
  • Global RegulatoryDatabase Training Seminar, Pfizer, certificate, 2005
  • Innovation approach to business, Pfizer, certificate, 2005
  • Electronic Management of Plant Artwork Documents, Pfizer, certificate, 2005
  • Artwork conformity, Pfizer, pass, 2005
  • Safety, adverse events: monitoring and reporting, Pfizer, pass, 2005
  • Global Net Conference on New PSUR (Periodic Safety Update Reports) System, Pfizer, certificate, 2004
  • Population pharmacokinetics/pharmacodynamics. Modeling. Individual pharmacotherapy., Research institute of physical and chemical medicine, Ministry of Health of Russia, May 2004, certificate, 2004
  • Seminar: Practical problems of drugs expertise, FGU Research Center,April 2004, certificate, 2004
  • Ophthalmologic training, Pfizer, certificate, 2004
  • PfLITE (database) Training Seminar, Pfizer, certificate, 2004
  • GRE, TOEFL, ETS, High, 1997
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