Regulatory Affairs Specialist Junior
3 settimane fa
Edge – Divisione di Eurosearch Consultants, specializzata nella ricerca e selezione di figure specialistiche e di middle management, ricerca per Azienda leader nella distribuzione delle materie prime, una figura di: REGULATORY AFFAIRS SPECIALIST JUNIOR Posizione: Responsabilità La risorsa, riportando al Direttore Affari Regolatori - Quality Assurance verrà inserita in un team di 5 persone e si occuperà: Dell'attività regulatory legate ai prodotti cosmetici, farmaceutici, nutraceutici e alimentari facenti parte del portafoglio prodotti; Gestione dell'aspetto regolatorio dei change: valutazione dell'impatto regolatorio, gestione dei contatti con l'eventuale fornitore, gestione della documentazione tecnica, classificazione della variazione e gestione di eventuali deficiency letter; Interfaccia con i partner coinvolti, sia UE che extra-UE, per le pratiche regolatorie specifiche del territorio; Capacità di revisione e aggiornamento della documentazione in base all'evoluzione della normativa e alle eventuali esigenze aziendali; Supporto all'allestimento di dossier per la registrazione di nuovi prodotti.
Requisiti: Requisiti Laurea in discipline Scientifiche (Farmacia, CTF, Chimica, Biologia); Esperienza da 1 a 3 anni in ambito regolatorio; Conoscenza della legislazione europea e italiana e delle linee guida ICH/EU relative ai principi attivi e alle materie prime trattate con applicazioni in ambito cosmetico, farmaceutico, alimentare e nutraceutico, maturata in analoghe posizioni in aziende di produzione o distribuzione di materie prime dedicate ai business di riferimento; Conoscenza dello sviluppo di dossier registrativi farmaceutici nel formato CTD; Conoscenza della gestione e presentazione delle domande di modifiche di AIC sia nazionali che di mutuo riconoscimento/decentrate/centralizzate e rinnovi; Buona conoscenza dell'inglese sia scritto sia parlato; Precisione, attenzione al dettaglio, flessibilità; Approccio proattivo e propositivo, autonomia e orientamento al problem solving; Visione strategica e capacità di identificare futuri rischi e opportunità normative; Altre informazioni: Sede di lavoro: Milano – Zona Forlanini Tipo di Contratto: Sostituzione Maternità finalizzato all'assunzione RIF: RASJR/ST Edge (Divisione di Eurosearch Consultants), incaricata della selezione, assicura la massima riservatezza.
La ricerca è estesa ad entrambi i sessi (L. 903/77).
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