Regulatory Affairs Associate
Remote · Seoul, Seoul, South Korea
Job Summary
Lead on site start-up and activation tasks for SSU in oncology in a home-based role in South Korea, including feasibility assessments, site identification, site contract negotiation, and coordinating regulatory submissions; provide SSU expertise to Study Start Up leads and project teams; ensure regulatory compliance and patient safety through development and review of Master and country-specific informed consent materials; collaborate with international teams in a fast-paced environment to drive study initiation and activation.
Required Qualifications
- Bachelor's degree or local equivalent in Medical/science background and/or discipline
- At least 3 years of experience or understanding of clinical regulatory affairs requirements and activities (e.g., IND submission and CMC)
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