Japan Regulatory Compliance Manager

Job description

Career CategoryRegulatoryJob DescriptionGroup 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) Bachelor’s degree (preferably in a scientific field). At least 5 years of pharmaceutical industry experience in regulatory-related activities. Education & Experience (Preferred) Master’s or Doctoral degree .