
SVITLANA SHKUNDINA
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von SVITLANA SHKUNDINA
- Current 9 years and 8 months, since Oct 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 year and 9 months, Nov 2014 - Jul 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 year and 1 month, Oct 2013 - Oct 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 year and 4 months, Jul 2012 - Oct 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 years and 6 months, Sep 2013 - Feb 2019
farmacia
National Pharmaceutical University, Kharkiv, Ukraine
Pharmacy
- 4 years and 10 months, Sep 2002 - Jun 2007
Ukrainian Language and literature
Kyiv National University of T. Shevchenko, Institute of Philology, Ukraine
Ukrainian and Ukrainian literature, English, creative writing
Sprachen
Russian
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
German
B1-B2 (Gute Kenntnisse)
Ukrainian
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