Senior Regulatory Scientist (Home Based)

About the role

ICON Clinical Research Korea is hiring a Senior Regulatory Scientist on a home-based basis in Seoul, South Korea. The role provides 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 risks
• 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 learning and development opportunities