Regulatory Submissions Manager

Regulatory Affairs Manager (FSP Global Pharma), 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.

Role: Manager Regulatory Affairs

Location: Home-based in Australia

We are currently seeking a Manager, Regulatory Affairs, to join our diverse and dynamic team, embedded within a single sponsor model. As a Manager, Regulatory Affairs at ICON, you will be partnering with a forward‑thinking global pharmaceutical company known for its strong commitment to innovation and patient‑focused science. With a deep heritage in developing transformative therapies across areas of high unmet medical need, this organisation continues to push the boundaries of what is possible in modern medicine.

You will have the opportunity to contribute to cutting‑edge research and development programs, supported by a culture that values curiosity, integrity, and continuous growth.

What you will be doing

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA

• Provide regulatory guidance and efforts to internal teams

• Participate in agency interactions and regulatory submissions

• Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines

• Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Your profile

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred

• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or Biotechnology industry

• Prior experience with various regulatory submissions, including CTA/IND/MAA

• Ability to lead internal teams and carry out regulatory activities independently

• Strong understanding of global regulatory requirements and guidelines

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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