Japan Regulatory Compliance Manager (Pharmaceuticals)

Location: Tokyo, Japan

Company

hirify.global's compliance group supports pharmaceutical business operations and compliance with Japan's Pharmaceuticals and Medical Device Act.

What you will do

• Support the Three Supervisors’ Committee through preparation of materials, meeting documentation, SOP management, inspection readiness, and training support.
• Manage MAH licensing and related regulatory compliance activities under the PMD Act.
• Prepare and maintain Foreign Manufacturer Accreditation and Foreign Manufacturer Registration applications and renewals.
• Coordinate GMP inspection preparation with the Quality team.
• Prepare regulatory submissions and support communication with MHLW, PMDA, and other health authorities.
• Process import certificates through NACCS, submit export notifications, and review promotional and non-promotional materials for regulatory compliance.

Requirements

• At least 5 years of pharmaceutical industry experience in regulatory-related activities.
• Practical knowledge of the PMD Act.
• Basic communication skills for interactions with PMDA and other health authorities.
• English proficiency required for document preparation and email communication.
• Basic IT skills, including business applications and document management systems.
• Bachelor’s degree, preferably in a scientific field.

Nice to have

• Master’s or doctoral degree.

Culture & Benefits

• Full-time employment in the pharmaceutical regulatory compliance function.
• Collaboration with Compliance, Quality, internal business functions, and health authorities.