Sponsor Dedicated Local Regulatory Associate - based in ROME In 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; 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

📌 Sponsor Dedicated Local Regulatory Associate - based in ROME (Milano)
🏢 Altro
📍 Milano