Japan Regulatory Compliance Manager
Amgen · Tokyo
Career Category
RegulatoryJob 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