We are seeking an accomplished Clinical Regulatory Director with 10-12 years of regulatory affairs experience gained within the pharmaceutical, biotechnology, CRO, or consulting sectors. This is a strategic leadership opportunity for a proven regulatory professional with a strong history of driving successful regulatory strategies, leading high-performing teams, and delivering impactful results across global development programs. The successful candidate will play a pivotal role in shaping regulatory direction, ensuring compliance, and accelerating the delivery of innovative therapies to patients worldwide.

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You will lead regulatory affairs activities and actively partner with subject matter experts across projects, providing strategic direction while guiding multidisciplinary teams to ensure the delivery of high-quality regulatory deliverables in alignment with business and customer objectives.

Key responsibilities include:

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- Develop and execute global regulatory strategies aligned with Target Product Profiles (TPPs) and Clinical Development Plans (CDPs).
- Lead the preparation, authoring, and submission of European Marketing Authorisation Applications (CP, MRP, and DCP) and oversee post-approval lifecycle management.
- Manage complex European regulatory pathways, including Orphan Drug Designations, Paediatric Investigation Plans (PIPs), and PRIME submissions.
- Lead regulatory agency interactions, including Scientific Advice meetings, while coaching internal teams and client SMEs to achieve successful outcomes.
- Provide strategic regulatory intelligence by interpreting evolving legislation and guidelines to support business decisions and strengthen regulatory partnerships.
- Collaborate cross-functionally with clinical, medical, quality, and commercial teams to drive successful product development and regulatory approvals.
- Ensure reg

📌 Director of Regulatory Affairs (Milano)
🏢 Upsilon Global
📍 Milano