Japan Regulatory Compliance Manager

Group Purpose

The Compliance Group is responsible for MAH business license Three-supervisors committee (Sanyaku-kaigi) Foreign Manufacturer Accreditation/ Foreign Manufacturer Registration (FMA/FMR) periodic GMP inspection and other activities to ensure compliance the Act on Pharmaceutical and Medical Device(PMD) Act. and to support the execution of the pharmaceutical business.

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.

Key Activities

• Perform MAH-related tasks: preparation and documentation for the Three Supervisors Committee SOP/document management inspection readiness and training support.
• Support FMA/FMR acquisition and renewal: application registration and communication with MHLW/PMDA.
• Contribute to GMP inspection preparation in collaboration with Quality team.
• Handle import certificates (Yakkan) via Nippon Automated Cargo and Port Consolidated System (NACCS) and export notifications in a timely manner.
• Conduct regulatory review of promotional and non-promotional materials in terms of applicable laws regulations and internal policies.

Knowledge and Skills

• 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).

Education & Experience (Basic)

• Bachelors degree (preferably in a scientific field).
• At least 5 years of pharmaceutical industry experience in regulatory-related activities.

Education & Experience (Preferred)

• Masters or Doctoral degree