Rakant Alla

Language proficiency: English - fluent
Autobiography
Моя профессия - Health Regulatory Affairs Manager (Registration Manager)
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.
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