Regulatory Affairs Support

2 giorni fa

Genova, Italia Nettowork Srl A tempo pieno

NETtoWORK, azienda italiana nata nel 2016, operante nel settore dei servizi, si occupa di soddisfare le necessità dei clienti offrendo servizi personalizzati.

Il nostro team si avvale anche di consulenti esperti nel settore, per supportare il cliente durante il periodo di collaborazione.

**Posizione**:
Ricerchiamo un **_Regulatory Affairs Support_**_, la_ risorsa si occuperà di:

- Supporto per le attività amministrative-regolatorie per ottemperare alle richieste di AIFA
- Supporto per l’allestimento di pratiche regolatorie da sottomettere ad AIFA (nuove AIC, variazioni tipo I-II, rinnovi, concessioni di vendita, trasferimenti titolarità, revoche)
- Supporto per la preparazione degli stampati dei medicinali e allestimento artworks
- Supporto per il mantenimento dei database aziendali
- Monitoraggio degli aggiornamenti normativi

**Requisiti**:
**Conoscenza, abilità e istruzione**:
***
- Conoscenza moduli CTD
- Conoscenza linee guida ICH/EU
- Conoscenza legislazione europea e italiana relativa ai medicinali
- Conoscenza di argomenti di tecnologia farmaceutica, GMP
- Conoscenza procedure MRP/DCP e Nazionali

**Altre informazioni**:
**Orario**: Dal Lunedì al Venerdì 8.30 - 13.00 / 14.00 - 17.30

**Sede di lavoro**: Lavagna (GE)

Non è previsto Smart Working

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