Regulatory and Site Start Up Specialist

Overview

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

What you'll do

• Prepare clinical trial application forms and submission dossiers for authorities and ethics committees.
• Interact with competent authorities and ethics committees and manage responses.
• Track site activation readiness, risks, submissions, and critical-path milestones.
• Collect and review essential documents for site activation and IMP release.
• Customize patient information sheets and informed consent forms.
• Coordinate document translations and communication across study functions.
• Maintain regulatory intelligence, audit readiness, and trial master file documentation.

What you'll need

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

Nice to have

• Pharmacy qualification or pharmacist 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 or RAC certification.

Details

• Location: Taiwan.
• Work mode: Remote.