Regulatory Affairs Specialist

3 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

**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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