Senior Regulatory Affairs Specialist

7 giorni fa


Vimercate, Lombardia, Italia Adecco A tempo pieno

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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