SVITLANA SHKUNDINA

Freiberuflich, Regulatory Affairs Specialist (CIS), Maxima Health Research LLC

Frankfurt Am Main, Deutschland

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

  • 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

    -

Interessen

Travelling
Cooking
HAnd-made beauty products
Literature
Psychology

21 Mio. XING Mitglieder, von A bis Z