Lavori attuali relativi a Regulatory Affairs Senior Manager - Milano - Confidenziale


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Regulatory Affairs Senior Manager

4 mesi fa


Milano, Italia Confidenziale A tempo pieno

Per conto di una realtà multinazionale farmaceutica con a Milano ricerchiamo un:
Regulatory Affairs Senior ManagerRispondendo direttamente all' Head of Regulatory and Drug Safety, la risorsa avrà le seguenti responsabilità:
Provvede in prima persona o attraverso i propri collaboratori alla registrazione, manutenzione dei medicinali gestendo domande AIC, il ciclo di vita dei medicinali, PBRER, DSUR; Garantisce l'aderenza alla normativa applicabile per medicinali ad uso umano e agli standard aziendali; Partecipa attivamente a gruppi di lavoro internazionali, collaborando con la funzione Regulatory globale, considerando le finalità di business e acquisendo leadership per un progetto |prodotto nel gruppo europeo; Collabora attivamente coi business partner locali per la gestione regolatoria deiprodotti in scope; Costruisce efficaci relazioni con gli interlocutori istituzionali e aziendali in ambito regolatorio, per assicurare informazioni tempestive ed aggiornate sulla normativa e sugli scenari prospettici. Profilo Conoscenza approfondita e comprensione dei e delle linee guida relative al Regolamento (ad es. Codici e normative locali di Pharma); Conoscenza dei processi ministeriali e dei funzionari del Ministero | AIFA; Buona padronanza della lingua inglese scritta e parlata. Completano il profilo:
Capacità relazionali e propensione al lavoro in team; Organizzazione, flessibilità, proattività, intraprendenza e orientamento al risultato. Regolatorio |Lombardia|Milano Pharma Point - Foro Buonaparte, 48 - 20121 Milano,