RAマネージャー/ RA Manager

An international biopharmaceutical company is looking for a Regulatory Affairs (RA) Manager. The selected candidate will support regulatory operations, maintain regulatory compliance, manage MAH-related activities, and coordinate regulatory submissions and communications with health authorities. This is a full remote setup role.

Responsibilities:

• Support the operation of the Three Supervisors’ Committee, including preparing meeting materials and documentation
• Perform MAH-related activities, including SOP and document management, inspection readiness, and training support
• Support FMA/FMR acquisition and renewal through application, registration, and communication with MHLW and PMDA
• Contribute to GMP inspection preparation in collaboration with the Quality team
• Handle import certificates (Yakkan) through NACCS and manage export notifications
• Prepare regulatory submission materials and support communication with health authorities
• Conduct regulatory reviews of promotional and non-promotional materials to ensure compliance with applicable laws, regulations, and internal policies
• Support MAH licence management and regulatory compliance activities in accordance with the PMD Act

Requirements:

• Bachelor’s degree or above in a scientific field
• More than 5 years of experience in regulatory-related activities within the pharmaceutical industry
• Practical knowledge of the PMD Act
• Basic communication skills for interactions with health authorities such as PMDA
• Basic IT skills, including business applications and document management systems
• Professional level Japanese and English

Preferred requirements:

• Master's or Doctoral degree

About the Company:

A global biopharmaceutical company focused on developing innovative therapies for serious illnesses. The organisation is recognised for advancing science through research, regulatory excellence, and patient-focused healthcare solutions.

Keywords:

薬事, 薬事申請, 規制対応, 医薬品, 規制コンプライアンス, 輸入許可, 求人, 外資系

Job Ref: F52NZE