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Regulatory Affairs Specialist
1 mese fa
NonStop Pharma è alla ricerca di un Regulatory Affairs Specialist per un'azienda farmaceutica con sede a Roma.
Unisciti a una realtà in crescita e leader nel settore di riferimento, che investe ogni anno il 15% del proprio fatturato in Ricerca & Sviluppo. Approfitta dell'opportunità di lavorare in un ambiente dinamico e innovativo, dove puoi contribuire al progresso e alla crescita aziendale.
Responsabilità principali:
- Gestione delle attività regolatorie relative al ciclo di vita dei medicinali (trasferimento titolarità, registrazioni, variazioni e rinnovi delle AIC) per procedure Nazionali, di Mutuo Riconoscimento, Decentrate e Centralizzate in conformità ai requisiti normativi EU e locali.
- Sottomissione e monitoraggio delle pratiche regolatorie mediante i principali portali EU.
- Allestimento di documenti amministrativi e redazione/revisione di documentazione tecnica (CTD- e-CTD) per medicinali nuovi e/o già parte del listino.
- Supporto operativo per la registrazione e il lancio di nuovi prodotti in Italia e all'estero, in accordo con le strategie definite dalla Direzione.
- Interfaccia con le Autorità competenti (AIFA, Ministero della Salute).
- Supporto alla Direzione nel mantenimento del Sistema di Gestione Qualità e di Farmacovigilanza, assicurando la conformità alle normative vigenti.
- Monitoraggio della legislazione vigente su Farmaci, Dispositivi Medici e Nutraceutici.
- Collaborazione con le funzioni QA, Farmacovigilanza e Direzione Medica.
Requisiti:
- Laurea in Chimica e Tecnologie Farmaceutiche o Farmacia.
- + 2 anni di esperienza nel ruolo in società di consulenza o aziende farmaceutiche.
- Conoscenza della normativa nazionale e internazionale sulla regolamentazione del farmaco;
- Inglese fluente.
- Residenza o disponibilita' ad un trasferimento su Roma.
E' previsto unnserimento in sostituzione maternità con previsione di contratto indeterminato.
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