Japan Regulatory Compliance Manager
amgen· 1112 Amgen K.K.
About this role
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
Frequently Asked Questions
Is the salary disclosed for the Japan Regulatory Compliance Manager position at amgen?
The salary for this Japan Regulatory Compliance Manager role at amgen is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Japan Regulatory Compliance Manager position at amgen located?
This Japan Regulatory Compliance Manager role at amgen is based in Japan - Tokyo. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Japan Regulatory Compliance Manager role at amgen full-time or part-time?
This is listed as a Full time position. It is posted as a Japan Regulatory Compliance Manager role in the 1112 Amgen K.K. department at amgen.
Which team or department does the Japan Regulatory Compliance Manager at amgen belong to?
This Japan Regulatory Compliance Manager position is part of the 1112 Amgen K.K. department at amgen. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Japan Regulatory Compliance Manager position at amgen?
Click the "Apply Now" button on this page. You will be redirected to amgen's official application portal hosted on workday where you can submit your application directly.
When was the Japan Regulatory Compliance Manager job at amgen posted?
This Japan Regulatory Compliance Manager position at amgen was posted on Jul 21, 2026. Apply as soon as possible — early applications are often reviewed first.
Japan Regulatory Compliance Manager
amgen
You'll be redirected to amgen's official application page on Workday.