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
