Safety & Regulatory Specialist – Taiwan

About the role

The Safety & Regulatory Specialist will support regulatory operations for clinical trials in Taiwan, ensuring compliance with TFDA, IRB and international GCP standards, and facilitating timely submissions.

Key responsibilities

• Oversee safety reporting processes, including receipt, assessment, processing and tracking of SAEs, EIU reports and other safety events.
• Generate case narratives and liaise with Medical Monitors and sponsor representatives.
• Act as Lead Safety Officer, maintaining oversight of regulatory compliance for assigned projects.
• Prepare, compile and submit clinical trial applications and amendments to TFDA and IRBs, and track regulatory changes.
• Liaise with TFDA, IRBs and other agencies to resolve queries and ensure timely evaluation.
• Perform quality control checks on Trial Master File content and regulatory submissions.
• Deliver training and guidance on regulatory requirements to project teams.

Required profile

• Bachelor’s degree or higher in life sciences, pharmacy or related field.
• 2‑4 years of regulatory affairs experience in clinical research, preferably within a CRO in Taiwan.
• In‑depth knowledge of IND processes, ICH‑GCP, TFDA and IRB requirements.
• Excellent written and verbal communication skills in Mandarin and English.
• Strong organizational and multitasking abilities.

Required skills

• Proficiency with clinical trial management systems.
• Experience using regulatory tracking tools.