Senior Global Regulatory Scientist

ICON; Sydney; Remote; AUD 150,000 - 210,000; Full time

Benefits offered by this job

Global health insurance

Flexible work arrangements

Life assurance

Employee assistance program

Job summary

ICON is a global healthcare intelligence and clinical research organisation committed to delivering faster access to medicines for patients. We seek a Global Senior Regulatory Scientist in Australia to provide high-level regulatory and scientific expertise across global development strategies and submissions.

You will mentor colleagues and lead cross-functional regulatory projects, ensuring robust regulatory positions, high-quality documents, and successful interactions with health authorities.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in regulatory affairs or regulatory science within pharma, biotech, and CRO environments.
• Strong knowledge of global clinical development regulations (FDA, EMA, ICH) and regional requirements.
• Excellent written and verbal communication abilities with meticulous attention to detail.
• Willingness to travel as required (approximately 10%).

Responsibilities

• Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
• Author and review complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
• Interpret evolving global regulations, guidelines, and precedents, advising teams on implications for programme design and execution.
• Provide strategic input into clinical development plans, risk management strategies, and labelling considerations.
• Represent regulatory functions in sponsor and health authority meetings with scientifically robust communication.
• Mentor junior regulatory colleagues and contribute to internal best practices and knowledge sharing.

Skills

Regulatory strategy

Regulatory writing

Cross-functional leadership

Data analysis

Mentoring

Education

Bachelor's degree in a relevant scientific discipline

Job description

Global Senior Regulatory Scientist - Australia - Remote Based

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Senior Global Regulatory Scientist at ICON, you will provide high-level regulatory and scientific expertise to support global development strategies and submissions.

Your experience in regulatory affairs will be key in delivering high-quality outcomes and mentoring colleagues.
Key responsibilities include:

• Leading the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
• Authoring and reviewing complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
• Interpreting evolving global regulations, guidelines, and precedents, and advising teams on implications for programme design and execution.
• Providing strategic input into clinical development plans, risk management strategies, and labelling considerations.
• Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
• Mentoring junior regulatory colleagues and contributing to internal best practices, templates, and knowledge-sharing initiatives.

You will have a strong foundation in regulatory affairs, with the experience to work independently and guide others.
Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in regulatory affairs or regulatory science within pharma, biotech, and CRO environments.
• Strong knowledge of global clinical development regulations (e.g., FDA, EMA, ICH) and regional requirements.
• Excellent scientific, analytical, and critical-thinking skills, with the ability to integrate complex data into regulatory positions.
• Outstanding written and verbal communication abilities, with meticulous attention to detail.
• Proven experience interacting with health authorities and leading cross-functional regulatory projects.
• Willingness to travel as required (approximately 10%)

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