CMC Regulatory Affairs Specialist
3 settimane fa
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.
- 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.
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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