Regulatory and Site Start Up Specialist
New
P
Precision for MedicineClinical Research
Remote, TaiwanFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 1 year or more as a Regulatory or SU specialist
Requirements
- Bachelor’s degree in life sciences, healthcare, or equivalent.
- 1 year or more experience as a Regulatory or SU specialist in a CRO or pharmaceutical/biotech industry.
- Strong communication and organizational skills.
- Proficiency in computerized information systems, electronic spreadsheets, and word processing.
- Fluency in English.
- Experience in regulatory and site start-up (feasibility, contract negotiations, submissions).
- Experience using milestone tracking tools.
Responsibilities
- Deliver site activation readiness within assigned country/sites.
- Prepare and submit Clinical Trial Application Forms and dossiers to Competent Authorities and Ethics Committees.
- Interaction with regulatory bodies and handling of queries.
- Maintenance of project plans, trackers, and regulatory intelligence tools.
- Support development of start-up plans and essential document review criteria.
- Collect and manage essential documents for site activation and IMP release.
- Coordinate and manage document translations.
- Facilitate study budget negotiation and contract execution.
- Maintain audit readiness and manage TMF documentation.
- Support pre-study site visits.
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