Japan Regulatory Compliance Manager
On-siteTokyo, Tokyo, Japan
Job Summary
Support the operation of the Three Supervisors' Committee (Sanyaku-kaigi) including preparation of materials and meeting documentation. Excuse MAH license management and regulatory compliance activities in accordance with the Pharmaceuticals and Medical Device (PMD) Act. Carry out FMA/FMR and GMP-related application and maintenance activities. Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions. Perform MAH-related tasks including SOP/document management, inspection readiness, and training support. Handle import certificates (Yakkan) via NACCS and export notifications. Conduct regulatory review of promotional and non-promotional materials. Requires Bachelor's degree with at least 5 years of pharmaceutical industry regulatory experience. Master's or Doctoral degree preferred.
Required Qualifications
- Practical knowledge of the PMD Act
- Basic communication skills for interactions with health authorities (PMDA, etc.)
- English proficiency for document preparation and email communication
- Basic IT skills (business applications, document management systems)
- Bachelor's degree (preferably in a scientific field)
- At least 5 years of pharmaceutical industry experience in regulatory-related activities
Desired Qualifications
- Master's or Doctoral degree
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