Job Overview
Location
Remote, South Korea
Job Type
Full-time
Category
HR & Recruiting
Date Posted
May 19, 2026
Full Job Description
đź“‹ Description
- • The Regulatory and Site Start Up Specialist plays a critical role in ensuring timely and compliant activation of clinical trial sites, directly contributing to the successful execution of precision medicine research in oncology, rare diseases, and other therapeutic areas.
- • 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 tools, and partnering with site CRAs to ensure alignment in communication and essential document collection for site activation and IMP release.
- • The role operates within Precision Medicine Group, a Clinical Research Organization dedicated to advancing precision medicine through integrated clinical trial design, biomarker analytics, medical expertise, and a passionate focus on rare diseases and oncology, supporting global clients in developing groundbreaking cancer therapies.
- • The specialist will deepen expertise in international and local regulatory requirements (ICH-GCP, national regulations), gain hands-on experience in site start-up lifecycle management, develop cross-functional collaboration skills with Clinical Operations, Project Management, and Site Contracts teams, and build proficiency in regulatory documentation, translation coordination, and audit/inspection readiness—positioning them for growth into senior regulatory or project leadership roles.
🎯 Requirements
- • Bachelor’s degree in life sciences or related field (scientific/healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- • 1 year or more experience as a Regulatory or Site Start-Up Specialist (or comparable role) in a CRO, pharmaceutical, or biotech industry.
- • Fluency in English and proficiency with computerized information systems, electronic spreadsheets, word processing, and email.
- • Strong communication and organizational skills.
- • Experience preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.
- • Ability to maintain audit/inspection readiness and manage documents per TMF or study-specific plans.
🏖️ Benefits
- • Opportunity to contribute to meaningful research in oncology and rare diseases with real patient impact.
- • Work within a growing, mission-driven organization that values employee input and nurtures ideas for positive change.
- • Remote work flexibility based in South Korea, enabling work-life balance while supporting global clinical trials.
- • Exposure to advanced biomarker and data analytics solutions integrated into clinical trial operations.
- • Professional development through hands-on experience with regulatory intelligence tools, milestone tracking systems, and cross-functional project collaboration.
- • Commitment to equal opportunity employment and reasonable accommodations for individuals with disabilities.
Skills & Technologies
About Precision Medicine Group
Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.
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