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Manager Regulatory Affairs
4 mesi fa
Manager Regulatory Affairs
(JSB.SRF.24.010)
da inserire all'interno della nostra divisione degli
affari regolatori .
Il candidato ideale ha una
laurea in discipline scientifiche
ed esperienza in ruoli di
Regulatory Affairs di almeno 7 anni , maturata in aziende farmaceutiche.
Il candidato nello specifico si occuperà di:
fornire una leadership normativa a sostegno dello sviluppo e della registrazione presso le autorità sanitarie internazionali (UE ed extra-UE) e della manutenzione dei prodotti di competenza; sviluppare e implementare strategie normative per raggiungere gli obiettivi di sviluppo e l'approvazione del prodotto e per supportare i progetti di gestione del ciclo di vita dei prodotti di competenza; assicurare che tutte le attività strategiche e tattiche siano condotte in conformità con le normative applicabili dalle autorità sanitarie locali e internazionali, lavorando a stretto contatto con i dipartimenti interni e con i team di progetto; assicurare una comunicazione chiara e tempestiva delle attività e dei progressi del progetto; supervisionare la pianificazione e il coordinamento delle regulatory submissions; gestire e supervisionare la preparazione e l'archiviazione delle proposte normative a supporto delle nuove attività di registrazione e di life-cycle management; autorizzare la presentazione di eCTD e gestisce i controlli sulle modifiche normative in collaborazione con partner interni ed esterni; assicurare la corretta formattazione, la completezza e la conformità ai requisiti normativi applicabili; attività gestionali di progetto; assicurare una tempestiva e appropriata gestione normativa delle modifiche ai prodotti per la CMC, la clinica e l'etichettatura.
Requisiti richiesti dal ruolo:
conoscenza delle linee guida ICH, AIFA, EU e delle normative e direttive internazionali; conoscenza delle norme GMP; ottima conoscenza della lingua inglese (scritto e parlato); disponibilità a trasferte su esigenza specifica del cliente; ottime capacità relazionali, gestionali e di pianificazione.
Sede di lavoro:
siamo in grado di offrire al candidato la possibilità di esprimere la propria preferenza fra una delle nostre sedi di Firenze, Milano e Parma
Modalità di lavoro:
formula mista Ufficio - Smart Working Legal Office & Headquarters: Via Di Calenzano 62, 50019 - Sesto Fiorentino (FI)
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