Director of Regulatory Affairs
Pubblicato il 13-08-2026 - Upsilon Global in Milano
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.
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:
- 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 regulatory compliance while identifying opportunities to accelerate development timelines and optimize submission strategies.
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