Sponsor Dedicated Local Regulatory Associate - based in ROME

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/786luz

ph3Sponsor Dedicated Local Regulatory Associate - based in ROME /h3pIn this role you will provide local Italian/EU regulatory expertise to manage a life-cycle portfolio of rare disease products. You will work closely with the Sponsor and internal teams, ensuring compliant local submissions, labeling, and promotional material reviews, and engaging with authorities such as AIFA. The position is Rome-based, with direct interaction with the Sponsor, regulatory authorities, and cross-functional departments. This is a hands-on regulatory role that drives local compliance and timely decision-making in a dynamic environment.



/pulliSupport local regulatory submissions and lifecycle activities for the sponsor's portfolio /liliProvide regulatory insight aligned with local and EU requirements /liliPrepare local labeling documentation and review Advertising and Promotional Material /liliInteract with AIFA and other authorities as required /liliCoordinate with Sponsor's local team and internal departments to ensure alignment /liliFacilitate communication with International Regulatory Affairs colleagues and external bodies /lili2-4 years of regulatory affairs experience in drug development/regulatory landscape /liliItalian mother tongue; proficient in English /liliExperience negotiating with Regulatory Authorities /liliAbility to assess complex scientific information and regulatory guidance for decision-making /liliExperience with Veeva RIM module /liliStrong written and verbal communication skills in Italian and English /liliCapability to plan, prioritize, and deliver projects in a cross-functional setting /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/786luz