Japan Regulatory Compliance Manager
Amgen • Tokyo, Tokyo, Japan
5日前
職務内容の詳細
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)
- Bachelors degree (preferably in a scientific field).
- At least 5 years of pharmaceutical industry experience in regulatory-related activities.
Education & Experience (Preferred)
- Masters or Doctoral degree
.
Required Experience:
Manager
Employment Type : Full-Time
Experience: years
Vacancy: 1