Experteer Overview In this role you drive global regulatory strategy to obtain and maintain marketing authorizations for rare disease-focused products. You will collaborate with international Health Authorities, subsidiaries, and partners to ensure compliance across life‐cycle filings. You shape regulatory documents and guide cross‐functional teams through submissions and lifecycle activities. You will translate complex science into clear regulatory strategies and report outcomes to senior management.
Retribuzione / Benefits Lead regulatory strategy, dossier management, and lifecycle activities for pre‐authorization and post‐authorization filings (e.g., ODDs, IMPD, IND, PIP, NDA, MAA; variations, renewals, annual reports)
Provide scientific and regulatory support to international subsidiaries and external partners
Monitor international legislation to keep the portfolio compliant with evolving standards




Oversee global filings progress and respond to Health Authority queries; approve labeling mock‐ups with production and partners
Manage CROs and external experts delivering regulatory work
Act as main contact for internal teams, subsidiaries, and external stakeholders (Health Authorities, Manufacturers, professional bodies)
Facilitate internal knowledge sharing on regulatory issues and report to senior management
Responsabilità 4 to 5 years in the pharmaceutical industry with proven regulatory affairs experience
Experience in Rare Disease or niche markets preferred
Proven experience with pre‐approval (IND/IMPD) and post‐approval dossiers (variations/renewals)
Strong ability to draft, review, and edit complex scientific and regulatory submissions
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📌 International Regulatory Affairs Project Manager (Italia)
🏢 Altro
📍 Italia