Associate Director/Manager, Global Regulatory Policy & Intelligence – Japan

About the role

This hybrid Regulatory Affairs position leads Japan Regulatory Policy & Intelligence while also supporting Development Regulatory Affairs for selected programs. Reporting to the Japan Regulatory Policy & Intelligence function, the role bridges policy strategy with product development execution.

Key responsibilities

• Lead regulatory policy strategy, monitor Japanese legislative trends, and provide intelligence to R&D and global teams.
• Represent Johnson & Johnson in industry associations (e.g., JPMA, PhRMA) and engage with PMDA, MHLW on policy advocacy.
• Serve on Japanese Clinical Development Teams, defining regulatory strategies, supporting submissions (CTN, NDA), and interacting with health authorities.
• Collaborate cross‑functionally with Japan Regulatory Affairs, Medical, Commercial and Global Regulatory leaders to align policy and development plans.

Required profile

• Extensive experience in pharmaceutical R&D or regulatory affairs within Japan.
• Strong knowledge of the Japanese regulatory framework and proven PMDA/MHLW interaction experience.
• Excellent communication skills in Japanese and English, with ability to work in a matrix organization.
• Strategic thinker capable of balancing policy leadership and development support.

Required skills

• Regulatory policy analysis and intelligence generation.
• Regulatory affairs execution for clinical development and submissions.
• Stakeholder engagement with health authorities, KOLs, and industry groups.
• Fluency in Japanese and English (verbal and written).