We are seeking a Regulatory & Site Start-Up Specialist (Levels I or II) to support the activation of clinical trial sites across Taiwan.
In this role, you will play a key part in ensuring clinical studies are approved, compliant, and initiated on time by managing regulatory submissions and coordinating with ethics committees, investigators, and internal study teams.
This is a great opportunity for someone with clinical trial regulatory or site start-up experience who enjoys working in a fast-paced, international environment.
Key Responsibilities
- Prepare and submit Clinical Trial Applications (CTA) and associated regulatory dossiers
- Manage submissions to Competent Authorities and Ethics Committees (IRB/EC)
- Track, manage, and respond to regulatory and ethics queries
- Drive site start-up readiness and ensure timely site activation
- Coordinate essential document collection and review for study sites
- Customize patient-facing documents (ICF / PIS) per local requirements
- Support translation coordination of regulatory and study documents
- Maintain Trial Master File (TMF) in an audit/inspection-ready state
- Collaborate with CRAs, Project Managers, Feasibility, and Contracts teams
- Track study milestones and provide regular updates to study leadership
- Ensure compliance with ICH-GCP and local regulatory requirements
- Support feasibility activities and site outreach where required
Requirements
Essential
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
- Minimum 1 year experience in Regulatory Affairs or Clinical Site Start-Up (CRO or pharma/biotech)
- Strong understanding of clinical trial processes (CTA / EC / IRB submissions)
- Excellent organisational and communication skills
- Fluent English (written and spoken)
- Proficiency with Microsoft Office and tracking tools (Excel, email systems, etc.)
Preferred
- 3–5 years experience in regulatory or site start-up roles (for Specialist II level)
- Pharmacist background highly advantageous
- Experience with milestone tracking systems
- Knowledge of clinical trial laws and regulations in Taiwan or APAC region
- Exposure to contract/budget coordination or feasibility support
- Advanced degree (MSc, PharmD, MD, PhD) or regulatory certification (e.g., RAC)
