About this role
About the Role ICON Strategic Solutions is seeking a Regulatory Affairs Expert focused on IND submissions and CMC activities from a home-based role in South Korea. You will support the Study Start Up team lead in developing and executing the plan for country and site distribution, with a focus on regulatory compliance, quality, and patient safety in a fast-paced environment. What You'll Do
- Lead on site start-up and activation tasks requiring technical depth, with an emphasis on quality and continuous improvement.
- Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
- Provide specialized SSU expertise to Study Start Up leads and project teams, offering insights to drive success.
- Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with applicable regulations and guidelines.
- Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, safeguarding patient welfare. What We're Looking For
- A Bachelor's degree or local equivalent with medical/science background and/or related discipline; at least 3 years of experience in clinical study start-up requirements.
- Experience with IND submissions and CMC activities (IND Submission and CMC Specialist) and ability to work with cross-functional teams.
- Fluency in the local language and English, enabling effective collaboration with international teams.
- Strong foundation in site start-up and activation and the ability to work independently and guide others. Compensation & Benefits
- Competitive salary and benefits package.
- Various annual leave entitlements.
- Health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme (LifeWorks) with 24-hour access to a global network of professionals.
- Life assurance and flexible country-specific optional benefits (e.g., childcare vouchers, bike purchase schemes, gym memberships, travel passes, health assessments).