Senior Regulatory Scientist
ICON · Seoul, South Korea
RegulatoryFull-timeCompany career page
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Role summary
Senior Regulatory Scientist position supporting global clinical development programs through regulatory strategy, document authoring, and health authority engagement. The role is home-based in Seoul and requires substantial CRO or pharma experience with clinical development regulations, strong scientific writing skills, and proven expertise in complex submissions and regulatory interactions.
What they're looking for
- Bachelor's degree in scientific or healthcare-related discipline
- Substantial regulatory affairs or regulatory science experience in pharma, biotech, or CRO
- Strong understanding of global clinical development regulations and guidance (FDA, EMA, ICH)
- Excellent scientific writing, analytical, and critical-thinking skills with attention to detail
- Proven experience supporting or leading health authority interactions and submissions
- Strong communication and collaboration abilities in cross-functional teams
- Willingness to travel approximately 5% as required
What you'll be doing
- Lead or significantly contribute to regulatory strategy development for clinical programmes
- Author and review complex regulatory documents including trial applications and submissions
- Interpret global regulations and advise cross-functional teams on regulatory expectations
- Participate in or lead health authority interactions and meeting preparation
- Mentor junior regulatory staff and develop internal standards and best practices
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.