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BeiGene | Japan, Japan | Posted June 16, 2026
Position Overview
Job Description:
General Description:
Local Representative for Regulatory Affairs, Local ComplianceProvide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase, with proactive input into commercial regulatory requirements during development.Act as an internal consultant on pharmaceutical regulations, including the PMD Act.Collect, analyze, and implement domestic pharmaceutical regulations; monitor and share regulatory trends (e.g., ICH, PIC/S, MHLW/PMDA).Promote regulatory awareness through internal briefings and materials on PMDA/MHLW updates and guidelines.Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.Oversee business license management (e.g., MAH, manufacturer) and collaborate with GQP/GVP departments.Package Insert (labeling) maintenance ...