Lead HGR application activities including preparation, submission, and maintenance
Collaborate strategically with stakeholders (CSL, ASML, ASUL, CSSU COM, CRA COM, CSSU, CRA, China
Provide best practice guidance to junior specialists
Drive preparation and submission of complex HGR applications
Oversee compilation and submission of ethics and local documents
Lead efforts to secure HGR, sample exportation, and CIQ approvals

🎯 Requirements

Bachelor's degree in life sciences, medicine, pharmacy, health sciences, or related field
5+ years of experience in pharmaceutical industry
3+ years focused on human genetic resource management
Comprehensive expertise in HGR regulations
Proven application of ICH GCP and clinical trial workflows
Strategic thinking abilities

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