Location
Tokyo, Japan, Japan
Posted
July 27, 2026
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 doc...
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 doc...