CMC Regulatory Affairs Specialist

3 settimane fa


Florence, Toscana, Italia ManpowerGroup A tempo pieno
Descrizione del Lavoro

Nel contesto di un cliente storico e prestigioso del settore farmaceutico, siamo alla ricerca di un/a CMC Regulatory Affairs Associate che si unisca al nostro team di conformità normativa CMC.

Responsabilità Principali
  • Organizzare attività per preparare il modulo 2.3 e 3 per la nuova applicazione e il mantenimento della registrazione esistente;
  • Lavorare in collaborazione con funzioni tecniche interne e team di regolamentazione o partner esterni per finalizzare il nuovo dossier di applicazione;
  • Finalizzare la parte di qualità dell'IMPD per i prodotti in fase di sviluppo del ciclo di vita;
  • Applicare i flussi di lavoro e le procedure aziendali esistenti;
  • Comprensione e monitoraggio del rilascio delle linee guida sulla qualità e del loro impatto sui progetti aziendali.
Requisiti Lavorativi
  • Laurea magistrale o superiore in campo scientifico;
  • Appartenenza alle Categorie Protette e Iscrizione al Collocamento Mirato;
  • Conoscenza FLUENTE della lingua Inglese;
  • Esperienza pregressa nell'ambito normativo è preferibile;
  • Capacità di lavorare in team e un buon atteggiamento di problem solving.
Caratteristiche del Lavoro

Il lavoro si svolgerà presso la nostra sede di Firenze Centro e prevede un contratto a Tempo Determinato 12 mesi con possibilità di conferma a Tempo Indeterminato.



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