Senior Regulatory Scientist, Home-Based in Australia

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Senior Regulatory Scientist working home-based in Australia, you will provide advanced regulatory and scientific expertise to support global clinical development strategies, submissions and interactions with health authorities, helping navigate complex regulatory landscapes.

Key responsibilities

• Take ownership of regulatory affairs deliverables and lead or significantly contribute to regulatory strategy for clinical programmes and key milestones
• Author and review complex regulatory documents such as clinical trial applications, briefing documents and major submission components
• Interpret global regulations, guidelines and precedents and advise cross-functional teams on regulatory expectations and risk
• Participate in or lead interactions with health authorities, including meeting preparation, presentation support and follow-up
• Provide regulatory input into clinical development plans, risk management strategies and labelling considerations
• Mentor junior regulatory staff and contribute to internal standards, templates and best practices

Required profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Substantial experience in regulatory affairs or regulatory science within pharma, biotech or CRO
• Proven experience supporting or leading health authority interactions and complex submissions
• Willingness to travel approximately 5% of the time
• Legal right to work in the country where the role is based

Required skills

• Strong understanding of global clinical development regulations and guidance (e.g. FDA, EMA, ICH)
• Excellent scientific writing, analytical and critical-thinking skills with meticulous attention to detail
• Strong communication and collaboration skills in cross-functional teams

What we offer

• 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