Regulatory Affairs Specialist

4 tygodni temu


Łódź, Polska HRK S.A. Pełny etat

Dla międzynarodowej firmy farmaceutycznej, poszukujemy doświadczonej osoby do działu rejestracji leków. 

Regulatory Affairs SpecialistMiejsce pracy: Łódź

Zadania:

  • Udział w opracowywaniu i wdrażaniu strategii regulacyjnej.
  • Monitorowanie informacji regulacyjnych i proaktywne działanie w zakresie zidentyfikowanych zmian w wymogach regulacyjnych.
  • Zarządzanie cyklem życia dokumentu w ramach Systemu Zarządzania Informacjami Regulacyjnymi.
  • Przygotowywanie dokumentów CMC (w szczególności modułu 2.3 i 3) dla dokumentacji, zapewniając ich zgodność z wymaganiami prawnymi na całym świecie.

Wymagania:

  • Doświadczenie w obszarze rejestracji produktów leczniczych.
  • Wykształcenie wyższe medyczne, farmaceutyczne, chemiczne, biologiczne lub pokrewne.
  • Dobra znajomość języka angielskiego w mowie i piśmie.
  • Umiejętności organizacyjne i zarządzania projektami.

Oferujemy:

  • Pracę w międzynarodowej firmie farmaceutycznej 
  • Stabilne zatrudnienie w oparciu o umowę o pracę 
  • Atrakcyjne wynagrodznie + pakiet benefitów 
  • Samodzielnosć w działaniu 
  • Możliwość rozwoju zawodowego. 


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