Senior Global Regulatory Scientist

Senior Regulatory Scientist, Sydney - Office 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.

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.