Senior Regulatory Affairs Specialist
7 giorni fa
Adecco per importante azienda cliente del settore farmaceutico veterinario, ricerca un/una
Senior Regulatory Affairs.
Responsabilità principali
- Gestione completa dei dossier regolatori (CESP, UPD): redazione, aggiornamento e mantenimento delle AIC.
- Coordinamento delle attività di registrazione, variazioni e submission verso le autorità competenti.
- Interazione con Ministero della Salute, EMA e consulenti regolatori.
- Monitoraggio delle normative e valutazione dell'impatto sui prodotti.
- Supporto alle attività di farmacovigilanza in collaborazione con QPPV e consulenti esterni.
Requisiti
- Laurea in
CTF, Farmacia, Medicina Veterinaria
o discipline affini. - Esperienza pluriennale
in Regulatory Affairs (minimo 3 anni), preferibilmente nel settore veterinario. - Conoscenza normativa GMP e requisiti regolatori.
- Ottime capacità di redazione tecnica e attenzione al dettaglio.
- Buona conoscenza della lingua inglese.
- Autonomia, affidabilità e capacità di lavorare in team trasversali.
Offriamo
- Inserimento in un contesto dinamico e strutturato.
- Ruolo con elevata autonomia e possibilità di interazione con funzioni strategiche (R&D, Qualità, Produzione).
- Contratto e retribuzione commisurati all'esperienza.
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