Regulatory Affairs Project Manager

1 giorno fa

Parma, Italia JSB SOLUTIONS S.R.L A tempo pieno

**JSB Solutions**, azienda nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) operante nel settore Life Science e che offre servizi di consulenza, servizi CRO e soluzioni software per le aziende farmaceutiche, biotecnologiche e industriali è alla ricerca di un **Regulatory Affairs Project Manager **_(Rif.SRF 22.032)_.
- Coordinamento e definizione degli obiettivi del team;
- Attività regolatorie (rinnovi, variazioni, registrazioni) nei paesi EU;
- Analisi dei requirements e gestione delle attività regolatorie (rinnovi, variazioni, registrationi) nei paesi extra-EU;
- Supporto alle filiali italiane per tutto il regolatorio post-market in accordo alla normativa Nazionale (AIFA front-end, POL, Convegni e congressi, RSS,ecc.).

**Requisiti richiesti dal ruolo**:

- Conseguimento di un corso in Project Management (requisito preferenziale);
- Conoscenza delle linee guida ICH, AIFA, EU e delle normative e direttive internazionali;
- Conoscenza delle norme GMP;
- Ottima conoscenza della lingua inglese (scritto e parlato);
- Disponibilità a trasferte su esigenza specifica del cliente;
- Elevate capacità comunicative con clienti esterni e interni;
**Sede di lavoro**:possibilità di inserimento in una delle nostre sedi di Firenze, Milano o Parma.

**Modalità di lavoro**:formula mista Ufficio - Smart Working

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