Regulatory Specialist
3 tygodni temu
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
- 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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