Japan Regulatory Compliance Manager

Career Category Regulatory Job Description 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) - 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 .