Ctry Approval Spec
Core
Manage Human Genetic Resource Application Center (HGRAC) applications and support human genetic resource management for clinical trials in China.
Role type
Regulatory specialist (clinical operations)
Builds
Regulatory compliance for clinical studies in China
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
HGRAC regulations, NMPA/CDE requirements, ICH-GCP, clinical trial management, project management, regulatory guidelines
Preferred skills
Science/medical background, English language, medical terminology
Technologies
Online application systems, database management
Responsibilities
Prepare and approve HGRAC application documents, track application status and feedback, maintain regulatory database, support strategic decision-making
Seniority
Individual Contributor
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