Regulatory Affairs Manager

5 mesi fa


Milano, Italia GUNA A tempo pieno

**RUOLO**: Regulatory Affairs Manager - Medical Devices

**DIPARTIMENTO**: Regolatorio

**JOB DESCRIPTION**:
Inserita nel Team Regolatorio e in collaborazione con i colleghi, la nuova risorsa avrà le seguenti responsabilità:

- Provvede all'istruzione delle pratiche di autorizzazione, di registrazione e di notifica dei prodotti (ad esempio: medical devices, integratori, cosmetici, omeopatici umani, mangimi complementari,...) in Italia e nei Paesi Esteri (UE e extra UE).
- Prepara la documentazione necessaria (dossier di registrazione) per l’ottenimento, il mantenimento e il rinnovo delle autorizzazioni all’immissione in commercio dei prodotti nel rispetto della normativa di riferimento e in collaborazione con le Funzioni aziendali coinvolte e i fornitori esterni.
- Gestisce le notifiche agli Enti regolatori (ad esempio: AIFA, Ministero della Salute, ISS,) richieste dalla normativa sul farmaco e i dispositivi medici (ad esempio: elenco degli Informatori Scientifici del Farmaco, data di immissione in commercio dei medicinali, prezzi,).
- Gestisce le pratiche di autorizzazione, registrazione e notifica dei prodotti in Italia e nei Paesi esteri, preparando la documentazione necessaria e mantenendo i rapporti con i fornitori e i distributori.
- Collabora alla gestione del materiale di marketing e di informazione scientifica in collaborazione con le Funzioni aziendali coinvolte.

**CITTÀ DI LAVORO**: Milano

**PROFILO**:
La nuova risorsa dovrà possedere i seguenti requisiti:

- Laurea in discipline scientifiche (CTF, Chimica, Biologia, Farmacia)
- Esperienza pregressa nel ruolo di Regulatory Affairs almeno 5 anni in ambito medical devices e preferibilmente anche in ambito farmaco
- Utilizzo in autonomia del pacchetto Office
- Attitudine manageriale nella gestione di progetti trasversali
- Ottime doti di precisione e attitudine al lavoro documentale
- Ottime doti relazionali e comunicative, predisposizione al lavoro di gruppo
- Capacità di analisi e problem solving

**CONOSCENZA LINGUE STRANIERE**: Buona conoscenza scritta e parlata della lingua inglese (Livello B2)

**TIPOLOGIA DI CONTRATTO**: Assunzione a tempo indeterminato



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