Regulatory Affairs Specialist Regulatory Affairs Specialis

2 settimane fa


Lainate, Italia HUNTERS GROUP A tempo pieno

**Responsabilità**:

- Gestire e coordinare le attività di regulatory affairs relative ai prodotti farmaceutici, dalla formulazione alla commercializzazione.
- Preparare e monitorare la documentazione per le ispezioni, interfacciandosi con le autorità regolatorie.
- Gestire le modifiche (change control) e le variazioni normative, garantendo che tutte le modifiche siano conformi alle normative locali e internazionali.
- Assicurare la compliance dei prodotti, monitorando costantemente le modifiche normative e regolatorie e implementando le relative azioni correttive.
- Collaborare con i team interni (R&D, produzione, marketing) per garantire che i prodotti siano sempre conformi alle normative vigenti.
- Supportare i colleghi nell'elaborazione di strategie e attività per l'approvazione dei prodotti.
- Fornire consulenza e supporto riguardo a regolamenti e pratiche da seguire per ottenere le necessarie approvazioni.
- Gestire il flusso di comunicazione con le autorità regolatorie, rispondendo a richieste e aggiornamenti relativi ai prodotti.

**Requisiti**:

- Almeno 2 / 3 anni di esperienza in Regulatory Affairs nel settore farmaceutico.
- Conoscenza delle normative locali e internazionali
- Esperienza in gestione delle ispezioni, change control, modifiche e variazioni.
- Conoscenza approfondita dei processi di compliance e delle normative di settore.
- Capacità di lavorare in modo autonomo e in team, con forte orientamento alla risoluzione dei problemi.
- Ottima capacità di comunicazione e gestione delle relazioni con le autorità regolatorie e i vari stakeholder aziendali.
- Laurea in discipline scientifiche (Farmacia, Chimica, Biologia, etc.) o titolo equivalente.
- Conoscenza fluente della lingua inglese, sia scritta che parlata.



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