Sr Ctry Approval Spec
On-site
Core
Manage Human Genetic Resource Application Center (HGRAC) applications and support human genetic resource management for clinical trials in China.
Role type
Senior regulatory specialist (clinical trials, China)
Builds
Regulatory compliance for clinical operations in China
Domain
Life sciences / Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
HGRAC regulations, NMPA/CDE requirements, ICH-GCP, clinical trial project management, document review and QC, regulatory database management, strategic decision support
Preferred skills
Science/medical degree, English language proficiency, medical terminology knowledge, digital literacy