Regulatory and Site Start Up Specialist

Overview

Manage regulatory submissions and site start-up activities for clinical trials in South Korea, supporting site activation readiness and compliance with applicable regulations.

What you'll do

• Prepare clinical trial applications and submission dossiers for competent authorities and ethics committees.
• Interact with authorities and ethics committees and manage responses.
• Collect, review, and maintain essential documents for site activation and IMP release.
• Customize patient information sheets and informed consent forms.
• Track submission timelines, project plans, and site activation deliverables.
• Coordinate with clinical operations, project management, regulatory, feasibility, and site contracts teams.
• Support site budget negotiations, investigator contracts, feasibility, visits, training, and process improvement when required.

What you'll need

• Bachelor's degree in life sciences or a related field, or registered nurse qualification, or equivalent education, training, and experience.
• At least 1 year of regulatory or site start-up experience in a CRO, pharmaceutical, or biotechnology setting, or equivalent relevant experience.
• Strong communication and organizational skills.
• Experience with computerized information systems, spreadsheets, word processing, and email.
• Fluency in English and Korean.

Nice to have

• South Korea-specific regulatory and site start-up experience.
• Experience with milestone tracking tools or systems.
• Advanced medical or life sciences degree, RAC certification, or a master's degree in regulatory science.

Details

• Remote role based in South Korea.