Regulatory Specialist and Senior Specialist
3 giorni fa
Adecco Lifescience, divisione specializzata del Gruppo Adecco, ricerca, per azienda leader nel settore pharma, una risorsa da inserire in qualità di:Regulatory Affairs SpecialistLa risorsa selezionata sarà inserita all'interno del team dedicato alla registrazione di prodotti medicinali a livello globale. Si occuperà di contribuire attivamente alle attività regolatorie necessarie per ottenere e mantenere le autorizzazioni all'immissione in commercio nei mercati internazionali, collaborando a stretto contatto con i dipartimenti interni e con le autorità regolatorie.Collaborare nella comunicazione con le autorità regolatorie rispondendo a richieste di chiarimenti e deficiency letters.Assicurare la conformità normativa dei prodotti aziendali rispetto alla legislazione vigente a livello europeo e internazionale.Collaborare con i team interni di sviluppo farmaceutico, qualità, produzione e affari clinici per fornire consulenza regolatoria durante tutto il ciclo di vita del prodotto.Requisiti:Laurea in Chimica e Tecnologia Farmaceutiche (CTF) e/o Farmacia.Almeno 2 anni di esperienza in ambito Regulatory Affairs nel settore farmaceutico, preferibilmente con responsabilità diretta nella gestione di sottomissioni regolatorie.Familiarità con le normative europee (EMA) ed internazionali (ICH, WHO) in ambito regolatorio, con focus su documentazione di qualità, tecnologie farmaceutiche e tecniche analitiche.Conoscenza approfondita di Direttive e Regolamenti UE, legislazione farmaceutica italiana, cGMP, Linee guida ICH/EMA.Eccellente padronanza della lingua inglese, sia scritta che parlata; la conoscenza di una seconda lingua è considerata un plus. Compenso e pacchetto retributivoSi offre inserimento diretto in azienda con contratto a tempo determinato di 12 mesi CCNL Chimico FarmaceuticoI candidati, nel rispetto del D.ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi;
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Roma, Italia Herbalife A tempo pienoA global nutrition company in Rome is seeking a Senior Specialist in Global Regulatory Affairs to ensure compliance with Italian and European regulations. The role involves collaborating with cross-functional teams and external bodies to obtain product approvals. Ideal candidates have a relevant degree, regulatory experience, and strong organizational...
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