Regulatory Affairs Specialist
2 tygodni temu
lokalizacja: łódzkie
numer referencyjny:
forma zatrudnienia: Pełny etat
Zakres obowiązków:
- Tworzenie dokumentów CMC (w szczególności modułów 2.3 i 3) dla dokumentacji, zapewniając zgodność z wymaganiami prawnymi na całym świecie.
- Zarządzanie cyklem życia dokumentów w ramach Systemu Zarządzania Informacjami Regulacyjnymi.
- Wspieranie procesu kontroli zmian we wszystkich fazach cyklu życia produktu.
- Śledzenie na bieżąco zmian w otoczeniu regulacyjnym i wymaganiach oraz przekazywanie informacji o tych zmianach wewnętrznym interesariuszom.
- Wspieranie procesu rejestracji suplementów diety i żywności specjalnego przeznaczenia medycznego.
- Udział w realizacji ważnych zadań firmy, takich jak opracowywanie strategii, działania związane z zachowaniem zgodności z przepisami, usprawnianie współpracy wewnątrz- i międzywydziałowej, optymalizacja procesów i standardów wewnętrznych, itp.
Wymagania:
- Wykształcenie wyższe z zakresu chemii, biologii, farmacji, biotechnologii lub innej pokrewnej dziedziny nauki lub techniki.
- Minimum 2-3 lata doświadczenia zawodowego w obszarze rejestracji w firmach farmaceutycznych.
- Doskonała znajomość wymagań technicznych dotyczących dokumentacji produktów leczniczych i suplementów diety na całym świecie (UE, ICH i inne).
- Dokładność, analityczność, niezależność, integracyjny i odpowiedzialny sposób pracy.
- Doskonałe umiejętności organizacyjne i zarządzania projektami, zdolność do pracy w zespole i realizacji zadań z zachowaniem wysokich standardów oraz w napiętych terminach.
- Doświadczenie w pracy z systemami zarządzania informacjami regulacyjnymi i bazami danych.
- Dobra znajomość języka angielskiego.
Nasza oferta:
- Praca pełna ekscytujących wyzwań, dająca szansę uczestniczenia w dynamicznym rozwoju międzynarodowej firmy farmaceutycznej.
- Stabilne zatrudnienie w pełnym wymiarze godzin na podstawie umowy o pracę.
- Możliwość uczestnictwa w interesujących projektach.
- Możliwość rozwoju zawodowego.
- Prywatna opieka medyczna.
- Ubezpieczenie na życie.
- Dofinansowanie do wypoczynku.
- Dopłata do Świąt Wielkanocnych i Bożego Narodzenia.
- Spotkania integracyjne.
- Przyjazna atmosfera i zaangażowany zespół współpracowników.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.
Hays Poland sp. z o.o. jest agencją zatrudnienia nr 361
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