Lavori attuali relativi a Regulatory Affairs Junior Azienda Chimico - Roma, Lazio - AXL Spa - Agenzia per il lavoro
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Global Regulatory Affairs Specialist
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Regulatory Affairs Junior Azienda Chimico
3 mesi fa
**ADDETTO/A AFFARI DEL REGOLATORIO - REGULATORY AFFAIRS**
La risorsa, a diretto riporto del Responsabile Affari Regolatorio, seguirà l'iter di registrazione dei prodotti aziendali, predisporrà la documentazione richiesta dalle autorità e manterrà aggiornata tale documentazione nei data base del Ministero della salute.
Le sue **mansioni** saranno:
- Mantenere il sistema aziendale aggiornato rispetto alle richieste di legge (Regulatory compliance)
- Gestire le registrazioni di prodotto e dell'azienda (Regulatory submissions)
- Assicurare il continuo mantenimento della conformità ai punti di cui sopra (Regulatory maintenance)
- Gestire le relazioni con le autorità regolatorie di competenza (Regulatory relationship)
- Il lavoro di mediazione ed interfaccia fra azienda ed organismi ministeriali che esaminano la documentazione.
Si **richiede**:
- Diploma di Laurea in facoltà scientifiche: Farmacia, CTF, Biologia, Biotecnologie, Chimica
- Conoscenza dell'inglese parlato e scritto
- Conoscenza dell'utilizzo dei sistemi informatici
- Adeguata conoscenza delle norme applicabili: UNI EN ISO 9001, UNI EN ISO 13485, DDM 93/42/CEE (recepita in Italia con DL n. 46/97) e ai loro aggiornamenti.
- Esperienza di almeno 1 anno in analoga posizione.
- Adeguata conoscenza del Sistema Qualità
Si** offre**:
- Contratto diretto con l'Azienda CCNL Chimico-Farmaceutico
- Orario di lavoro: Lunedì - Venerdì 08.30/17.30
- Luogo di lavoro: Roma Sud / Est