Regulatory and Site Start Up Specialist

New

Precision Medicine GroupClinical 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 of experience as a Regulatory or SU specialist in a CRO or pharmaceutical/biotech industry
Strong communication and organizational skills
Proficiency in computerized information systems, spreadsheets, and word processing
Fluency in English

Responsibilities

Deliver site activation readiness with timeliness and quality
Prepare Clinical Trial Application Forms and submission dossiers for CAs and ECs
Manage interactions and responses for CAs and ECs
Maintain project plans, trackers, and regulatory intelligence tools
Customize country/site specific Patient Information Sheets and Informed Consent Forms
Coordinate document translations
Act as SME for site-level critical path to site activation
Support negotiation of study budgets and execution of investigator contracts
Maintain audit/inspection readiness and TMF filing

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