ppWe 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. /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-18808-Ljbffr

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