REGULATORY AFFAIRS MANAGER

3 giorni fa

Milan, Italia Altro A tempo pieno

REGULATORY AFFAIRS MANAGER Per un nostro cliente, azienda farmaceutica attiva in Italia e all’estero con un importante progetto di ricerca e sviluppo in oftalmologia, stiamo cercando una figura diIl candidato – sotto la direzione del Responsabile Affari Regolatori Pharma – garantirà le seguenti attività :Seguire lo sviluppo dei prodotti farmaceutici al fine di garantire la conformità alle linee guida dell’UERedazione dell’IMPDPreparare i documenti di risposta per le lettere di carenzePreparazione e follow-up della Richiesta di Scientific AdviceGestione della procedura PIPCoordinamento con terze parti per le diverse sottomissioni regolatoriePartecipare agli Advisory Board con i medici per raccogliere informazioni utili allo sviluppo di nuovi prodotti farmaceutici e dispositivi mediciLaurea magistrale in CTF, Farmacia o Chimica;Conoscenza del pacchetto Office;Conoscenza fluente della lingua inglese;Capacità organizzative, curiosità e attitudine al lavoro in team;Buona capacità di revisione documentale e di redazione di documentazione esplicativa.Esperienza nel settore di almeno 5-6 anniSede : Milano.#J-18808-Ljbffr

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