Senior Regulatory Scientist, Sydney - Office Based
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent 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.
What You Will Do:
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.
Your Profile:
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, or 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%)
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Perks may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.

📌 Senior Global Regulatory Scientist (New South Wales)
🏢 ICON Clinical Research
📍 New South Wales