Senior Manager or Associate Director, Lifecycle RA

BeiGene · Japan, Japan, Japan

Location

Japan

Job Type

Full time

Posted

June 23, 2026

Job Description

Job Description:
General Description: 
Local Representative for Regulatory Affairs, Local Compliance
Provide 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 ...
        

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