Regulatory Affairs Manager

7 giorni fa

Lazio, Italia Iqvia A tempo pieno

Per l'area CSO (Contract Sales Organization) ricerchiamo un/una Regulatory Affairs Manager.La risorsa prenderà in gestione principalmente le attività di stampo regolatorio e medico in relazione a un portafoglio prodotti variegato in area Specialty e Retail per un'azienda multinazionale leader.ResponsabilitàSupervisione regolatoria sull'attività di produzione materiali per la promozione medico-scientifica (materiale promozionale e di disease awareness)Gestione a tuttotondo del servizio medico-scientifico: dal supporto al team Marketing nella creazione dei contenuti fino alla revisione del materiale finale (definendo i perimetri regolatori previsti)Gestione delle sottomissioni regolatorie dei materiali comunicativi ad AIFA

in compliance con i requisiti normativi e con interazione diretta con i relativi funzionari– fungendo da punto di contatto principale tra l'azienda e le autorità regolatorie, gestendo le comunicazioni e rispondendo alle richieste di informazioniCollaborazione con il referente del servizio medico-scientifico IQVIA per la gestione di tutte le attività afferenti a tale responsabilità, compresa la stesura e l'aggiornamento delle SOP nonché il mantenimento del relativo sistema di qualitàMonitoraggio post-marketing: gestione delle attività di sorveglianza post-marketing per monitorare la conformità alle normative in ambito promozionaleFormazione del personale: organizzazione e conduzione di sessioni di formazione per la field-force relativamente a normative,

procedure di conformità e contenuti medico-scientifici di prodotto.Requisiti Laurea in discipline scientifiche (CTF, Farmacia, Medicina e Chirurgia)Esperienza di 6-8 anni in Dipartimenti di Regulatory Affairs/Servizio Scientifico di aziende farmaceutiche o società di consulenza regolatorieConoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di medicinali e codici deontologiciPrecisione, accuratezza e cura dei dettagliEccellenti capacità organizzative e rispetto delle scadenze definiteCapacità di lavorare sia in team che in autonomiaAlta dose di flessibilità, dinamicità e buona capacità di adattamentoBuone capacità comunicative sia scritte che verbaliOttimo inglese, sia scritto che orale (costante necessità di relazione con interlocutori Global)Sede di lavoro: MilanoIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at SummaryLocation: Milan, ItalyType: Full time

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