Regulatory Affairs Officer

3 settimane fa

Milan, Italia Altro A tempo pieno

Pharma D&S , società del gruppo PLG, è una società di consulenza nel settore Farmaceutico e Lifesciences in grado di fornire servizi tempestivi, efficienti e di elevata qualità nell’ambito di: Quality & Process, Regulatory Affairs, Farmacovigilanza e Studi Clinici.Cerchiamo un/a Regulatory Affairs Officer da inserire nel team di Cassina de’ Pecchi (MI) o Roma con almeno 2 anni di esperienza, con l’obiettivo di supportare start-up e aziende consolidate nel garantire un accesso al mercato rapido ed efficace dei loro prodotti.Responsabilità PrincipaliFornire consulenza regolatoria ai clienti, affiancandoli nelle attività necessarie per l’ingresso e il mantenimento sul mercato.Gestire attività pre-autorizzative, nuove registrazioni e sottomissioni regolatorie post-autorizzative, interfacciandosi con le autorità sanitarie competenti per conto dei clienti.Curare la preparazione, la revisione e il monitoraggio della documentazione regolatoria, assicurando la corretta tracciabilità delle sottomissioni e delle relative approvazioni.Revisionare formati e contenuti di packaging texts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL) e labelling, garantendone la conformità ai requisiti normativi.Effettuare attività continuative di regulatory monitoring/regulatory intelligence e comunicare tempestivamente ai team eventuali aggiornamenti rilevanti.Analizzare la normativa vigente e valutarne l’impatto sui prodotti o sulle attività dei clienti, fornendo indicazioni operative chiare e puntuali.Chi CerchiamoEsperienza pregressa di almeno 2 anni in ambito farmaceutico.Laurea triennale e laurea magistrale, preferibilmente in Farmacia, Medicina o CTF – Chimica e Tecnologie Farmaceutiche.Ottima conoscenza della lingua inglese.Ottime capacità organizzative e rispetto delle scadenze definite.Ottime competenze relazionali.Buona conoscenza dei principali strumenti informatici.Perché Unirti a NoiEntrare in Pharma D&S significa contribuire alla crescita di una realtà leader nella consulenza per il settore Farmaceutico e Life Sciences, in un contesto dinamico, internazionale e in continua evoluzione. Offriamo un ambiente di lavoro collaborativo, orientato all’innovazione e alla valorizzazione delle persone, dove potrai mettere a frutto la tua esperienza e sviluppare il tuo potenziale.Sede di lavoro: Cassina de' Pecchi (MI) / RomaModalità di lavoro: Formula ibrida ufficio – smart working#J-18808-Ljbffr

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