SVITLANA SHKUNDINA
Freiberuflich, Regulatory Affairs Specialist (CIS), Maxima Health Research LLC
Frankfurt Am Main, Deutschland
Werdegang
Berufserfahrung von SVITLANA SHKUNDINA
Bis heute 7 Jahre und 8 Monate, seit Okt. 2016
Regulatory Affairs Specialist (CIS)
Maxima Health Research LLC
Registration /renewal/ variations of medicinal products, medical devices and food supplements; communication with partners; expertise of materials received from the partners; compiling of registration materials for dossier in CTD and local format for CIS countries: coordination of submissions and control of procedures in CIS countries.
1 Jahr und 9 Monate, Nov. 2014 - Juli 2016
Regulatory Affairs Specialist
Kievmedpreparat LLC
Registration / renewal of medicinal products and substances in Ukraine and CIS countries; variations in registration materials; expertise of materials of modules 3, 4, 5; compiling of registration materials for dossier in CTD format.
1 Jahr und 1 Monat, Okt. 2013 - Okt. 2014
Regulatory Affairs Specialist
PHARMEX GROUP LLC
Registration / renewal of medicinal products, in bulk products and substances in Ukraine and Vietnam; variations in registration materials; compiling of registration materials for dossier in CTD format; proofreading of registration documents before receiving MA; organization of department’s work concerning proofreading of artworks/ instructions for typography and State Inspectorate on medicinal products; correspondence with partners.
1 Jahr und 4 Monate, Juli 2012 - Okt. 2013
Regulatory Affairs Specialist
S PHARMA LLC
Registration / renewal of medicinal products, compiling of registration materials for dossier in CTD format; correspondence with partners.
Ausbildung von SVITLANA SHKUNDINA
5 Jahre und 6 Monate, Sep. 2013 - Feb. 2019
farmacia
National Pharmaceutical University, Kharkiv, Ukraine
Pharmacy
4 Jahre und 10 Monate, Sep. 2002 - Juni 2007
Ukrainian Language and literature
Kyiv National University of T. Shevchenko, Institute of Philology, Ukraine
Ukrainian and Ukrainian literature, English, creative writing
Sprachen
Russisch
Muttersprache
Englisch
Fließend
Deutsch
Gut
Ukrainian
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