Regulatory Affairs Officer
7 mesi fa
**Healthcare & Pharma di ADHR Group, specializzata nella selezione di professionisti nel settore sanitario e farmaceutico, ricerca per prestigiosa azienda leader nel settore farmaceutico un/a**:
**REGULATORY AFFAIRS OFFICER**
**Le mansioni principali includono**:
- Collaborare con il Regulatory Manager di gruppo nella redazione di dichiarazioni e modulistica richiesta dai clienti, con focus emissione di certificati di conformità alle principali normative
- Redazione della documentazione per l'ottenimento ed il mantenimento delle autorizzazioni all'ammissione in commercio dei prodotti
- Gestione delle pratiche di registrazione presso le Autorità Regolatorie nazionali ed internazionali
- Preparazione ed aggiornamento dei dossier di registrazione e stesura e revisione dei fascicoli tecnici
- Redazione schede di sicurezza e scenari espositivi
- Interfaccia con i fornitori e gestione della documentazione técnica e regolatoria di accompagnamento ai prodotti
- Collaborazione con team R&D per la valutazione regolatoria delle formulazioni in fase di sviluppo
- Gestione delle non conformità prodotto con interfaccia fornitori e clienti
**Requisiti richiesti**:
- Laurea Magistrale in CTF / Farmacia / Chimica o equipollenti
- 3/4 anni di esperienza in ruoli simili
- Conoscenza normativa ICH, EU Clinical Trial Regulation e altre normative globali
- Conoscenza dell'inglese
**Offriamo**:
- Contratto di lavoro con inserimento diretto a tempo indeterminato commisurato all'esperienza
- CCNL Chimico-Farmaceutico
**Sede di lavoro**:Milano
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