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Regulatory Affairs Specialist

3 mesi fa

Milano, Italia Nonstop Consulting A tempo pieno

NonStop Pharma è alla ricerca di un Regulatory Affairs Specialist per un'azienda farmaceutica cliente su Milano.
Hai piu' di un anno di esperienza nel Regolatorio Farmaceutico e sei alla ricerca di una posizione che ti consenta di ampliare le tue competenze e crescere professionalemente?
Questa posizione ti permettera' lavorare con una vasta gamma di prodotti a marchio (350 referenze) acquisendo un'ottima expertise su farmaci, dispositivi medici, integratori e parafarmaci.
Responsabilità principali: Il candidato, sotto la supervisione diretta del RAF Manager, sarà responsabile delle seguenti attività:
Gestione regolatoria del fascicolo tecnico dei Medical Devices e IVD di cui è titolare il cliente. Approvazione di grafiche, notifiche agli enti competenti, richieste di autorizzazioni pubblicitarie e gestione di capitolati e contratti con fornitori di Dispositivi Medici e IVD. Collaborazione con diverse funzioni aziendali per la gestione del ciclo di vita dei prodotti. Stesura, revisione e aggiornamento del Manuale della Qualità (MdQ) e delle Standard Operating Procedures (SOP). Gestione di variazioni, rinnovi, revoche, capitolati e contratti con i fornitori. Elaborazione e verifica dei testi da sottomettere e/o approvati dall'Agenzia Italiana del Farmaco (AIFA). Gestione della Sunset Clause, pubblicazioni in Gazzetta Ufficiale, contatti con fornitori e gestione degli ordini di bollini farmaceutici. Mantenimento del modulo 3 CTD e conversione in e-CTD. Requisiti: Laurea in materie scientifiche (farmacia, CTF, chimica, chimica industriale). +1 anno di esperienza nel Regolatorio Farmaceutico . Conoscenza approfondita della normativa e dei regolamenti relativi a farmaci, dispositivi medici e parafarmaci. Buona conoscenza dell'inglese, in particolare del linguaggio tecnico. Residenza o disponibilita' ad un trasferimento su Milano. Qualora fossi interessato/a e il tuo profilo fosse in linea con i requisiti non esitare ad inviare il tuo curriculum in formato word a Marianna Ferrara all`indirizzo [email protected]
Chiedo scusa in anticipo nel caso non dovessi rispondere a ciascuno di voi dato l`elevato numero di curriculum che ricevo.
La NonStop Consulting e` un`azienda leader di mercato nel settore dell`Healthcare e membro di APSCo, un'organizzazione devota all'assicurazione della qualita' dei servizi nel mondo del recruitment a livello globale. Per avere un`idea piu` chiara dei nostri servizi visita il nostro sito web: