European Regulatory CMC Manager

1 mese fa


Milan, Italia Hays A tempo pieno
La tua nuova azienda Il nostro cliente è una realtà multinazionale che produce e commercializza prodotti farmaceutici generici. Il tuo nuovo ruolo In ottica dell’ampliamento dell’organico, siamo alla ricerca di una figura di European Regulatory CMC Manager

La risorsa risponderà direttamente al General Director e si occuperà degli aspetti legati alla parte CMC (Chemical Manufacturing and Control), interni al Modulo 3 CTD, per prodotti farmaceutici da sottomettere ad EMA (o Agenzie europee) e originati dall’Headquarter (EMS Brasile) o dalle Consociate (Galenika AD Belgrado, Germed Portogallo). La risorsa sarà anche coinvolta (unitamente al coinvolgimento di consulenti) alla creazione delle sezioni CMC per prodotti ad uso investigazionale in Europa e/o Stati Uniti (IMPD, IND). Tra le mansioni assegnate alla risorsa:

Revisione e integrazione del Modulo 3 (CMC) relativo a prodotti farmaceutici per successiva sottomissione EU Preventiva Gap Analysis (CMC) dei medesimi Dossiers, in funzione delle linee guida armonizzate (ICH) in vigore e dei requisiti GMP. Coordinamento di consulenti esterni, review del lavoro dei consulenti ed assemblaggio delle sezioni al fine di completare i contenuti del Modulo 3 nei tempi previsti con la casa madre Elaborazione di strategie e risposte derivate da Deficiencies o richieste di integrazione da parte delle autorità regolatorie in corso di submission Supporto al settore QA e alla QP durante le visite ispettive delle agenzie regolatorie Allineamento strategico e tecnico con i Regulatory Affairs Managers della casa madre (EMS Brasile) e delle consociate europee Partecipazione alla definizione dei requisiti CMC per l’allestimento di IMPD e IND di prodotti ad uso clinico. Di cosa hai bisogno per aver successo Si richiede un’esperienza pregressa di 4-5 anni in ruolo analogo, in un contesto farmaceutico.

Si richiede buona conoscenza della lingua inglese con l’Headquarter e le consociate EU. Si richiede un’esperienza pregressa di 4-5 anni in ruolo analogo, in un contesto farmaceutico. Cosa devi fare ora Se sei interessato a questa opportunità, clicca su "Candidarsi ora" per inviare una copia aggiornate del tuo CV. Se questa opportunità non è in linea con le tue aspettative, ma sei alla ricerca di un nuovo lavoro, visita il nostro sito Internet per scoprirne di nuove. I candidati di ambo i sessi, dopo aver visionato l'informativa obbligatoria sulla privacy sul sito www.hays.it, sono pregati di inviare il CV in formato Word, indicando il riferimento (Rif. 941576). #LI-DNI #941576 - Martina D'andrea #J-18808-Ljbffr
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