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About the Role

The Compliance Group ensures adherence to the Act on Pharmaceutical and Medical Device (PMD) Act and supports pharmaceutical business execution through managing MAH business licenses, the Three-supervisors’ committee, Foreign Manufacturer Accreditation/Registration, and periodic GMP inspections.

Responsibilities

• Support the operation of the Three Supervisors’ Committee, including material preparation and meeting documentation.
• Manage MAH license and ensure regulatory compliance according to the PMD Act.
• Execute FMA/FMR and GMP-related application and maintenance.
• Prepare regulatory submission materials and facilitate communication with health authorities.
• Perform MAH-related tasks such as Three Supervisors’ Committee preparation, SOP/document management, inspection readiness, and training support.
• Support FMA/FMR acquisition and renewal, including application, registration, and communication with MHLW/PMDA.
• Contribute to GMP inspection preparation in collaboration with the Quality team.
• Handle import certificates (Yakkan) via NACCS and export notifications.
• Conduct regulatory review of promotional and non-promotional materials against applicable laws, regulations, and internal policies.

Requirements

• 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).
• At least 5 years of pharmaceutical industry experience in regulatory-related activities.

Skills

• PMD Act knowledge
• Health authority communication
• English proficiency
• IT skills
• Document management
• SOP management
• Inspection readiness
• Training support
• Application and registration
• Regulatory review
• NACCS system usage

Experience Level

• 5+ years of pharmaceutical industry experience in regulatory-related activities

Education Level

• Bachelor’s degree (preferably in a scientific field)
• Master’s or Doctoral degree