Descrizione:
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.
Act as a trusted regulatory leader, delivering expert guidance throughout the product development and commercialization lifecycle.
Required Qualifications And Experience
Education: At least a Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred.
Experience: 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.
Strategic & Technical Ability: Deep expertise in developing regulatory strategies (TPPs, CDPs), combined with self-sufficiency in technical document writing and submission management.
Leadership Skill: Strong leadership skills and a proven ability to manage cross-functional teams and complex projects in a collaborative environment.
Communication: Excellent interpersonal, stakeholder management, and agency negotiation skills, with the ability to influence and drive change in a complex organization.
Travel: Willingness to travel as required (approximately 25%).
What We Can Offer You
Our 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.
In 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.
Our Benefits Examples Include
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global 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.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
If 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.
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