Regulatory and Site Start Up Specialist

Overview

Support regulatory submissions and site activation for clinical trials in Taiwan, ensuring required approvals, documents, and site readiness are delivered on time and to quality standards.

What you'll do

• Prepare clinical trial application forms and submission dossiers for authorities and ethics committees.
• Manage communications and responses with Competent Authorities and Ethics Committees.
• Track submissions, timelines, risks, deliverables, and site activation milestones.
• Collect and review essential documents for site activation and IMP release.
• Customize patient information and informed consent documents and coordinate translations.
• Coordinate start-up activities with regulatory, clinical operations, feasibility, project management, and contracts teams.
• Maintain regulatory knowledge, audit readiness, and relevant Trial Master File documentation.

What you'll need

• Bachelor’s degree in life sciences or a related field, RN qualification, or equivalent education and experience.
• At least 1 year of experience as a Regulatory or Site Start-Up Specialist or in a comparable role.
• Strong communication and organizational skills.
• Experience with computerized information systems, spreadsheets, word processing, and email.
• Fluency in English.
• Ability to prioritize workload and meet deadlines.

Nice to have

• Pharmacy qualification or pharmacist work experience.
• Regulatory and site start-up experience, including feasibility, contract negotiations, and authority or ethics submissions.
• Experience with milestone tracking tools or systems.
• Advanced medical or life sciences degree, RAC certification, or a Master’s in Regulatory Science.

Details

• Location: Taiwan.
• Work mode: Remote.