SVITLANA SHKUNDINA

Freiberuflich, Regulatory Affairs Specialist (CIS), Maxima Health Research LLC
Frankfurt Am Main, Germany

Fähigkeiten und Kenntnisse

CTD
Regulatory Affairs
Registration
Regulatory
CIS countries
Regularory adviser
Drug product
Medical device
Medical translation
7+ years expirience in RA
Audits
International registration
Project Coordination
German language
English Language
Russian Language

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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