Offer summary
Qualifications:
Bachelor’s degree in life sciences or related field, 1 year experience as a Regulatory or SU specialist, Experience in submissions to Taiwan FDA, Strong communication and organizational skills, Fluency in English.
Key responsabilities:
- Ensure site activation readiness and mitigate risks
- Prepare Clinical Trial Application Forms and submission dossiers
- Maintain project plans and regulatory intelligence tools
- Coordinate with teams for study updates and essential document collection
- Keep informed about clinical trial laws and maintain audit readiness