About this role
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
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