Regulatory Affairs Specialist

Gefunden in: Talent CH C2 - vor 1 Woche

Lugano, Schweiz IBSA Group Vollzeit


Posizione aperta
Regulatory Affairs Specialist

La nuova risorsa verrà inserita all’interno dell’area di registrazione Extra-EU (tutti i paesi del mondo esclusi EU-CH-USA-Canada). 

Il profilo ricercato si occuperà di:

Allestimento della documentazione necessaria per i nuovi processi registrativi nei paesi extra-Europei: raccolta documenti in accordo alle check list paese specifico submission attraverso i partner locali follow-up del processo registrativo fino all’ottenimento della MA Preparazione delle variazioni volte al mantenimento del life cycle delle registrazioni in essere nei paesi extra-Europei: valutazione impatto della variazione a livello locale raccolta documenti e submission attraverso i partner locali follow-up Costante monitoraggio con i partner locali delle line guida locali nei vari paesi extra EU

Valutazione degli impatti regolatori con i vari partner locali dei cambi proposti ai dossier di registrazione

Profilo ricercato: laurea in discipline scientifiche (farmacia, chimica e tecnologie farmaceutiche, biologia, biotecnologie e affini) 2-3 anni di esperienza in procedure amministrative in ambito regolatorio, possibilmente in area extra-EU buona conoscenza della lingua inglese conoscenza dei sistemi informatici MS (word, excel, power point) predisposizione alla organizzazione e al lavoro di team.

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