Katarzyna Piskorska-Małolepsza

Ekspert at SciencePharma
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Contact Information
us****@****om
(386) 825-5501
Location
Warsaw Metropolitan Area, PL
Languages
  • English -
Skills

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Experience

  • SciencePharma
    • Poland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Ekspert
      • Jul 2022 - Present

    • Senior Regulatory Affairs Specialist (CMC)
      • Oct 2019 - Jul 2022

      CMC Department:- preparation of post-approval variations- review/assessment of the medicinal products dossier (Module 3 and 2.3) in view of current ICH/EMA/FDA guidelines- preparation and management the dossier during registration procedure

    • Regulatory Affairs Specialist (CMC)
      • Apr 2018 - Oct 2019

    • Regulatory Affairs/ CMC Young Specialist
      • Jan 2018 - Mar 2018

  • Samodzielny Publiczny Kliniczny Szpital Okulistyczny
    • Warszawa, woj. mazowieckie, Polska
    • Technik medyczny
      • Jan 2017 - Dec 2017

  • The Infant Jesus Teaching Hospital in Warsaw (Szpital Kliniczny Dzieciątka Jezus w Warszawie)
    • Mikrobiolog
      • Jul 2016 - Dec 2017

  • Medical University of Warsaw
    • Hospitals and Health Care
    • 100 - 200 Employee
    • PHD Candidate
      • Sep 2012 - Dec 2017

      Lectures and classes for students of:-Polish and English Division Medical Faculty-Dentistry Faculty (polish students)-Midwifery Faculty (polish students)-Dietetics Faculty (polish students)-Public Health Faculty (polish students)Conducting courses of specialization in the field of Medical Mycology for :- Medical analytics- Biologists and Biotechnologists

    • Laboratory Technician
      • Oct 2013 - Oct 2014

  • The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
    • Poland
    • Government Administration
    • 1 - 100 Employee
    • Regulatory affairs coordinator
      • Jan 2016 - Jul 2016

      regulatory affairs coordinator in National procedure and European procedures (renewals, withdrawals, cooperation with other units: variation, registration, pharmacovigilance) regulatory affairs coordinator in National procedure and European procedures (renewals, withdrawals, cooperation with other units: variation, registration, pharmacovigilance)

  • Samodzielny Publiczny Centralny Szpital Kliniczny Banacha
    • Warsaw Area, Poland
    • Laboratory Technician
      • Jul 2014 - Oct 2015

Education

  • Warszawski Uniwersytet Medyczny
    Doktor nauk medycznych, 2016
    2012 - 2016
  • Szkoła Główna Gospodarstwa Wiejskiego w Warszawie
    Master of Science (M.Sc.), Microbiology, General
    2007 - 2012
  • Szkoła Główna Gospodarstwa Wiejskiego w Warszawie
    Magister (Mgr)

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