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Ctry Approval Spec

Shanghai, China💼 Full-time🗓 2026-09-11 → 2026-09-25

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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