ppWe are seeking an accomplished Clinical Regulatory Director with ***** 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.
/p pYou 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.
/p h3Key responsibilities include: /h3 ul liDevelop and execute global regulatory strategies aligned with Target Product Profiles (TPPs) and Clinical Development Plans (CDPs).
/li liLead the preparation, authoring, and submission of European Marketing Authorisation Applications (CP, MRP, and DCP) and oversee post-approval lifecycle management.
/li liManage complex European regulatory pathways, including Orphan Drug Designations, Paediatric Investigation Plans (PIPs), and PRIME submissions.
/li liLead regulatory agency interactions, including Scientific Advice meetings, while coaching internal teams and client SMEs to achieve successful outcomes.




/li liProvide strategic regulatory intelligence by interpreting evolving legislation and guidelines to support business decisions and strengthen regulatory partnerships.
/li liCollaborate cross-functionally with clinical, medical, quality, and commercial teams to drive successful product development and regulatory approvals.
/li liEnsure regulatory compliance while identifying opportunities to accelerate development timelines and optimize submission strategies.
/li liAct as a trusted regulatory leader, delivering expert guidance throughout the product development and commercialization lifecycle.
/li /ul h3Required Qualifications And Experience /h3 ul liEducation: At least a Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred.
/li liExperience: Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry, with a proven history of managing European regulatory procedures (CP/DCP) and post-authorization activities.
Candidates with advanced therapy or international market experience are particularly welcome although this is not essential.
/li liStrategic Technical Ability: Deep expertise in developing regulatory strategies (TPPs, CDPs), combined with self-sufficiency in technical document writing and submission management.
/li liLeadership Skill:



Strong leadership skills and a proven ability to manage cross-functional teams and complex projects in a collaborative environment.
/li liCommunication: Excellent interpersonal, stakeholder management, and agency negotiation skills, with the ability to influence and drive change in a complex organization.
/li liTravel: Willingness to travel as required (approximately 25%).
/li /ul h3What We Can Offer You /h3 pOur success depends on the quality of our people.
That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
/p pIn addition to your competitive salary, there is a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
/p h3Our Benefits Examples Include /h3 ul liVarious annual leave entitlements /li liA range of health insurance offerings to suit you and your family's needs.
/li liCompetitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
/li liGlobal Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
/li liLife assurance /li liFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
/li /ul pIf you're looking to make a meaningful impact in the future of immune-oncology while leading innovative global clinical programs, we'd love to hear from you.
/p /p #J-*****-Ljbffr

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