Senior Global Regulatory Scientist

About the role

ICON is seeking a Senior Global Regulatory Scientist to provide high‑level regulatory and scientific expertise supporting global development strategies and submissions. The role is office‑based in Sydney and involves mentoring colleagues and representing regulatory functions in sponsor and health‑authority meetings.

Key responsibilities

• Lead development of global regulatory strategies for clinical programmes, including health‑authority interaction plans.
• 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 programme design and execution.
• Provide strategic input into clinical development plans, risk‑management strategies, and labeling considerations.
• Represent regulatory functions in sponsor and health‑authority meetings, ensuring clear, scientifically robust communication.
• Mentor junior regulatory colleagues and contribute to internal best‑practice templates and knowledge‑sharing initiatives.

Required profile

• Strong foundation in regulatory affairs with ability to work independently and guide others.
• Bachelor's degree in a relevant scientific or healthcare‑related discipline.
• Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments.
• Proven experience interacting with health authorities and leading cross‑functional regulatory projects.
• Willingness to travel approximately 10% as required.

Required skills

• Knowledge of global clinical development regulations (e.g., FDA, EMA, ICH).
• Excellent scientific, analytical, and critical‑thinking abilities.
• Outstanding written and verbal communication skills with meticulous attention to detail.

What we offer

• Competitive base salary and performance‑related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage.
• 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.