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Maryna Filonenko

Senior Manager Regulatory Affairs at Hetero
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Maryna Filonenko, a seasoned professional with 8+ years of experience in regulatory affairs, holds a PhD in Toxicology from the Institute of Pharmacology and Toxicology, and a Master's in Biochemistry from Taras Shevchenko National University of Kyiv.
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Location
Ukraine, UA
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Maryna Filonenko is a seasoned regulatory affairs expert with a strong academic background in toxicology and biochemistry. As a Science Specialist at the Institute of Pharmacogy and Toxicology, she honed her expertise in neuropharmacology. Her extensive experience spans over three decades, including stints as a Project Lead, Deputy Head of Regulatory Affairs Department, and Senior Manager Regulatory Affairs at Hetero, Apotex Inc., and Pharma Start, respectively.

Experience

  • Hetero
    • Kyiv City, Ukraine
    • Senior Manager Regulatory Affairs
      • Oct 2015 - Present
      • Kyiv City, Ukraine

  • Apotex Inc.
    • Kyiv City, Ukraine
    • Project Lead
      • Sep 2012 - Jul 2015
      • Kyiv City, Ukraine

      Registration, renewal and variations for finish medicinal products dossiers in Ukraine.PV back-up in Ukrainian represenative office.Implementation of corporate SOPs in RO and creation of local SOPs.Training refer to new local SOPs and PV requirements.

  • Pharma Start
    • Kyiv City, Ukraine
    • Deputy Head of Regulatory Affairs Department
      • 2007 - 2012
      • Kyiv City, Ukraine

      Clinical trials dossiers, registration, renewal and life-time supporting of API and finish medicinal products support, coordination plans and other tasks with different plant departments involving into dossier support and manufacturing process.

  • Institute of Pharmacogy and Toxicology, Kyiv, Ukraine
    • Kyiv City, Ukraine
    • Science Specialist
      • 1989 - 2006
      • Kyiv City, Ukraine

      Neuropharmacology

Education

  • 1993 - 1998
    Institute of Pharmacology and Toxicology, Kyiv, Ukraine
    Doctor of Philosophy - PhD, Toxicology
  • 1987 - 1993
    Taras Shevchenko National University of Kyiv
    Master of Science - MS, Biology and Chemistr

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Industry Focus. “Pharmaceutical Manufacturing”

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