Japan Regulatory Compliance Manager

About the role

Amgen is hiring a Regulatory Compliance Manager in Japan within its Compliance Group. The group ensures compliance with the Pharmaceuticals and Medical Devices (PMD) Act and supports the execution of pharmaceutical business, covering MAH licensing, foreign manufacturer accreditation, GMP inspections and related activities.

Key responsibilities

• Support the operation of the Three Supervisors' Committee (Sanyaku-kaigi), including preparation of materials and meeting documentation.
• Manage MAH license and regulatory compliance activities under the PMD Act.
• Handle FMA/FMR and GMP-related applications and maintenance.
• Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions.
• Contribute to GMP inspection preparation with the Quality team.
• Handle import certificates (Yakkan) via NACCS and export notifications in a timely manner.
• Review promotional and non-promotional materials against applicable laws, regulations and internal policies.

Required profile

• Bachelor's degree (preferably in a scientific field).
• At least 5 years of pharmaceutical industry experience in regulatory-related activities.
• Preferred: Master's or doctoral degree.

Required skills

• Practical knowledge of the PMD Act.
• Basic communication skills with health authorities such as the PMDA.
• English proficiency for document preparation and email communication.
• Basic IT skills (business applications, document management systems).