Technical Regulatory Associate
3 settimane fa
**About Johnson & Johnson**
**Laureati in Discipline Scientifiche - Technical Regulatory Associate, tempo determinato**
Janssen SPA rappresenta il settore farmaceutico del gruppo Johnson & Johnson e commercializza oltre 30 specialità medicinali afferenti a cinque diverse aree terapeutiche con l'obiettivo di offrire soluzioni terapeutiche all'avanguardia rispondenti ad elevati standard di efficacia e sicurezza.
Nello specifico la risorsa scelta sarà inserita nell' **area Quality Systems - Technical Regulatory **, che ha la responsabilità di assicurare, attraverso la verifica del rispetto di procedure operative standard e mediante opportuni strumenti, che la qualità del prodotto sia conforme alle specifiche e normative vigenti (GMP).
Le attività previste dal ruolo comprendono:
- Preparare la documentazione di registrazione internazionale in collaborazione con il reparto CMC Regulatory Affairs e clienti esterni, mantenendo i contatti presso i corrispondenti enti Janssen Beerse per ottimizzare lo scambio efficace di informazioni ed il flusso della documentazione richiesta dalle affiliate nei paesi per le rispettive autorità.
- Preparare la documentazione di registrazione locale in collaborazione con il Regulatory Affairs di Janssen-Cilag, Milano.
- Eseguire la raccolta e l’elaborazione di tutte le informazioni e le certificazioni richieste dalle diverse affiliate per le rispettive autorità, in aggiunta alla documentazione di registrazione.
- Compilare i master data (es. SAP) di pertinenza regolatoria relativamente ai nuovi codici di prodotti e materiali e relativi cambi, inclusa la corretta implementazione della shelf-life, in linea con le procedure di gestione.
- Esecuzioni dei controlli di compliance regolatoria dei lotti prodotti a scopo clinico come da procedura di gestione.
- Assicurare la corretta archiviazione dei documenti redatti ai fini registrativi, in accordo alle procedure di gestione, in modo da garantire la disponibilità e la preparazione alle ispezioni.
**Qualifications**:
- Laurea magistrale in Chimica e Tecnologie Farmaceutiche, Farmacia, Chimica o Biologia;
- Minima esperienza pregressa in aziende farmaceutiche;
- Ottima conoscenza della lingua inglese;
- Buona conoscenza del pacchetto office.
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