Regulatory Project Manager – Technical Lead

Senior Manger Regulatory Affairs - Home-based in Australia

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.

Are you ready to take the lead on meaningful regulatory projects across the APAC region? We’re looking for a forward-thinking Regulatory Project Manager who thrives in a client-facing environment, brings strong technical expertise, and enjoys guiding others to grow.

What you will be doing:

• Act as a technical leader and consultant across a diverse portfolio of regulatory projects.

• Serve as the primary liaison between clients and internal project teams, ensuring seamless communication and trusted partnerships.

• Lead end-to-end project delivery—from kick-off to close-out—using best-practice project management methodologies.

• Provide regulatory submission expertise, including deep knowledge of HA processes and submission content requirements.

• Offer strategic insights to shape submission planning and operational delivery.

• Coordinate project activities, develop and maintain timelines, dashboards, and visuals, and keep the wider team aligned.

• Deliver financial oversight, including budget tracking, accrual reviews, and timely invoice approvals.

• Support BD efforts across APAC, contributing to proposals and helping junior staff build their BD capability.

• Mentor and develop junior colleagues by delegating tasks with clear guidance and structured oversight.

Your profile:

• Solid technical experience in one or more relevant areas: Regulatory Affairs, Clinical, Drug Development, Program/Project Management, or similar.
• Strong understanding of regulatory submission pathways, documentation, and Health Authority processes.
• Advanced skills with MS Project, Excel, OnePager, EDMS, and other regulatory/project management tools.
• Demonstrated project management strengths across planning, team coordination, and stakeholder communication.
• Experience managing project financials, including budgeting and accruals.
• A collaborative mindset with a passion for coaching and developing others.
• PMP or similar project management certification is highly regarded.

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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 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply