証明書スペシャリスト/ Certificates Specialist

A global regulatory solutions and services company is looking for a Certificates Specialist. The selected candidate will manage applications for GMP certificates and manufacturing licenses while coordinating with stakeholders.

Responsibilities:

• Process CPP, GMP, and manufacturing license applications to PMDA
• Coordinate with stakeholders and CMO sites to secure GMP and ML certificates
• Liaise with client entities to obtain letters, declarations, and notarisation
• Manage requests through the PSS Certificate tool
• Receive certificates from CMO sites or PMDA and dispatch to requesters
• Prepare and maintain dashboards for performance communication

Requirements:

• Bachelor’s degree or above in science or a relevant domain
• 2-5 years of professional experience
• Experience in handling Japan’s PMDA HA submissions and applications for COPP, GMP, and ML
• Knowledge of statutory documents
• Excellent interpersonal communication skills

About the Company:

A leading global provider of regulatory solutions and services, specialising in compliance, labeling, and regulatory affairs support. Offers end-to-end expertise across pharmaceuticals, medical devices, cosmetics, and food supplements industries.

Keywords:

規制遵守、GMP認証、認証書管理、求人, 外資系

Job Ref: 3ZRY6L