Regulatory Affairs Specialist

1 settimana fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
**MAIN SCOPE OF THE POSITION / RESPONSIBILITIES**:

- Allestimento della documentazione relativa al rinnovo ed estensione delle Autorizzazioni relative al sito di Patheon Monza, tra cui Autorizzazione alla Produzione/Importazione (Italia e RoW), Autorizzazione all'Impiego di Sostanze Stupefacenti e Psicotrope, Licenza Precursori di Droghe di Categoria 1, richieste di DEA;
- Mantenimento dello stato di compliance regolatoria del sito di Patheon Monza attraverso:

- il recepimento degli input esterni in termini di normative (Direttive, Regolamenti, Leggi italiane, cGMP, Linee Guida ICH, EMA, FDA) e di policies Corporate;
- la stesura dei change controls di sito e/o la valutazione dell'impatto regolatorio degli stessi;
- la stesura/revisione dei documenti di Specifica, come da procedura interna, a partire dal dossier di registrazione e/o dalla documentazione ufficiale del cliente e attraverso contatto diretto con i fornitori;
- Stesura/aggiornamento delle SOP di reparto
- Aggiornamento degli archivi e di database elettronici di reparto ivi inclusi quelli per la catalogazione della documentazione di registrazione ricevuta dai Clienti.

**REQUIREMENTS**
- Laurea in Chimica, CTF, Farmacia o Biologia

**Technical and PC knowledge**:

- Conoscenze di base della struttura organizzativa di uno stabilimento farmaceutico
- Conoscenze di base di técnica farmaceutica e delle tecniche di analisi
- Conoscenza di cGMP, Linee Guida, CFR

**Professional Experience**:

- Almeno due anni di esperienza nella funzione Regulatory Affairs in una azienda approvata FDA

**Foreign Languages**:

- Inglese tecnico scritto e parlato

**Personality traits**:

- Attitudini analitiche
- Attitudini comunicative
- Capacità relazionali
- Empatia sviluppata

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