RA Director

A global biopharmaceutical company is seeking an RA Director. The selected candidate will manage regulatory projects, build stakeholder relationships, and ensure compliance and budget control.

Responsibilities:

• Lead regulatory strategy and liaise with PMDA and other regulatory bodies
• Oversee documentation, audits, and compliance for Japan-based projects
• Coordinate with internal and external teams to drive regulatory execution
• Support cross-border partnerships by providing regulatory insights
• Build strong networks with authorities, consultants, and vendors
• Supervise project budgets and ensure regulatory process efficiency

Requirements:

• Bachelor’s degree or equivalent
• More than 10 years of experience in a relevant regulatory work
• Experience with GXP, PMDA regulations, and ICH guidance
• Prior experience with PMDA
• Proven experience with NMPA/FDA/EMA is a plus
• Background in assessment of regulatory risk and feasibility in multiple disease areas is ideal
• Proficient in MS Office Suite
• Possess valid Pharmacist licence
• Proficient in written and spoken English and Japanese

About the Company:

A biopharmaceutical company focused on the research, development, and commercialisation of high-quality, affordable biologic medicines. It specialises in oncology, autoimmune diseases, and other therapeutic areas, with a strong commitment to innovation and global healthcare access.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 13FJJQ