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Precision for Medicine is seeking a Regulatory and Start Up Specialist to join their team in South Korea. This role is crucial for ensuring the timely and quality delivery of site activation readiness. The Regulatory Specialist will handle the preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.Responsibilities include:
- Preparing submission dossiers for regulatory bodies.
- Interacting with regulatory authorities and ethics committees.
- Providing updates on submissions to relevant team members.
- Maintaining project plans and regulatory intelligence tools.
- Supporting the development of study-specific start-up plans.
- Ensuring alignment in communication with site CRAs.
- Customizing patient information sheets and informed consent forms.
- Coordinating document translations.
- Maintaining site-level critical path data.
- Supporting budget negotiations and investigator contracts.
- Keeping updated on local clinical trial laws and regulations.
- Maintaining audit/inspection readiness.
- Supporting pre-study site visits.
- Bachelor’s degree in life sciences or related field.
- 1+ years of experience as a Regulatory or Start-Up Specialist.
- Strong communication and organizational skills.
- Experience with computerized information systems.
- Fluency in English.
- Opportunity to impact positive change for the company.
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.