Sponsor Dedicated Local Regulatory Associate - Based In Rome

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cn2fw

Sponsor Dedicated Local Regulatory Associate - based in ROMEIn 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.
Support local regulatory submissions and lifecycle activities for the sponsor's portfolio
Provide regulatory insight aligned with local and EU requirements
Prepare local labeling documentation and review Advertising and Promotional Material




Interact with AIFA and other authorities as required
Coordinate with Sponsor's local team and internal departments to ensure alignment
Facilitate communication with International Regulatory Affairs colleagues and external bodies
2-4 years of regulatory affairs experience in drug development/regulatory landscape
Italian mother tongue; xysqume proficient in English
Experience negotiating with Regulatory Authorities
Ability to assess complex scientific information and regulatory guidance for decision-making
Experience with Veeva RIM module
Strong written and verbal communication skills in Italian and English
Capability to plan, prioritize, and deliver projects in a cross-functional setting
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cn2fw