Director, Regulatory Affairs

3 tygodni temu

Warszawa, Mazovia, Polska ICON Pełny etat

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as Director, Regulatory Affairs.

This is an exciting opportunity for a strategic leader passionate about clinical development and regulatory submissions. If you thrive in a fast-paced, global environment and want to shape the future of oncology submissions, apply today

What you will be doing:

Join our team as Director, Regulatory Affairs and play a critical role in driving clinical submission strategies for Phase 3 regulatory marketing applications and beyond. This is a Regulatory Affairs-focused position requiring strong project management skills and a deep understanding of clinical development across multiple phases—not just post-approval or CMC.

  • Lead cross-functional Clinical Submission Teams, ensuring timely and high-quality submission deliverables.
  • Oversee clinical contributions to regulatory marketing applications across multiple markets.
  • Collaborate with Clinical, Regulatory, Biometrics, and Safety teams to align submission goals.
  • Develop and manage submission timelines, risk mitigation plans, and governance materials.
  • Act as an escalation point for clinical functional leads to resolve operational issues.
  • Contribute to process improvements and regulatory submission best practices.

You are:

  • Bachelor's degree in medical, biological sciences, or a related field (Advanced degree preferred).
  • 10+ years in pharmaceutical, biotech, or a large multinational organization.
  • Experience in clinical development, regulatory submissions, and marketing applications.
  • Strong project management skills, with experience leading cross-functional teams.
  • Background in multiple drug development phases, particularly Phase 3.
  • Familiarity with MS Project and other project management tools.
  • Project Management certification (PMP) and process improvement methodologies (Lean Sigma, Change Management).
  • Oncology experience is required.

What ICON 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, ICON offers 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 maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through this form.

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