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🥝 Senior Manager or Associate Director, Lifecycle RA

BeiGene | Japan, Japan | Posted June 17, 2026

Senior Manager or Associate Director, Lifecycle RA

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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