Regulatory Specialist

3 tygodni temu


Warsaw, Polska Zentiva Group Pełny etat
Specjalista ds. Rejestracji

miejsce pracy: biuro w Warszawie

praca hybrydowa

Twój zakres obowiązków
  • Nadzór nad procesami nowych rejestracji produktów leczniczych w procedurach europejskich (MRP, DCP, CP), koordynacja fazy narodowej rejestracji
  • Weryfikowanie projektów graficznych ulotek i opakowań produktów leczniczych
  • Zapewnienie prawidłowej implementacji zmian porejestracyjnych
  • Przygotowanie, tłumaczenie i weryfikacja druków informacyjnych
  • Zapewnienie prawidłowej komunikacji i współpracy z odpowiednimi lokalnymi organami regulacyjnymi
  • Współpraca z centralnym działem RA oraz wewnętrznymi działami firmy
Nasze wymagania
  • Wykształcenie wyższe: farmaceutyczne, medyczne, chemiczne, biologiczne lub pokrewne uzupełnione specjalistycznymi szkoleniami
  • Co najmniej 3 letnie doświadczenie związane z prowadzeniem procesów rejestracyjnych w procedurach europejskich (MRP, DCP, CP) i narodowych
  • Biegła znajomość języka angielskiego w mowie i w piśmie
  • Znajomość prawa farmaceutycznego i wymaganej dokumentacji dla produktu leczniczego
  • Dobra znajomość obsługi pakietu MS Office, e-CTD
  • Sumienność, odpowiedzialność, skrupulatność, terminowość
  • Bardzo dobra organizacja pracy, umiejętność ustalania priorytetów
  • Umiejętność rozwiązywania problemów i samodzielność w działaniu
  • Wysokie kompetencje interpersonalne, umiejętność pracy w zespole


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