Regulatory and Site Start Up Specialist

📋 Description

• • As a Regulatory and Site Start Up Specialist at Precision Medicine Group, you will play a critical role in ensuring the timely and compliant activation of clinical trial sites in South Korea, directly contributing to the advancement of oncology and rare disease therapies through precision medicine initiatives.
• • Your day-to-day responsibilities include preparing and submitting Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees, managing site activation timelines, coordinating document translations, maintaining regulatory intelligence and project trackers, and collaborating with CRAs, Project Managers, and Site Contract teams to secure site readiness and IMP release.
• • You will join a growing, mission-driven Clinical Research Organization that integrates clinical trial design, biomarker analytics, and medical expertise to accelerate breakthrough therapies, with a strong focus on rare diseases and oncology across global therapeutic areas.
• • In this role, you will deepen your expertise in international and local regulatory frameworks (ICH-GCP, country-specific regulations), gain hands-on experience in site start-up lifecycle management, and develop cross-functional collaboration skills while contributing to audit-ready documentation and TMF compliance in a dynamic, innovative CRO environment.