Manager II, RA TA Group, Regulatory Affairs(Immunology)

📋 Description

• Lead regulatory affairs activities for complex or high-impact projects across assigned therapeutic
• Serve as a regulatory lead and key strategic partner within cross-functional project teams (e.g.
• Develop, optimize, and implement regulatory strategies that address complex regulatory challenges
• Act as a senior point of contact for interactions with PMDA/MHLW, leading regulatory
• Identify, assess, and manage regulatory risks, including scenario planning and development of
• Coach, support, and train RA team members, sharing expertise, reviewing key deliverables, and

🎯 Requirements

• Advanced Regulatory Expertise: Strong and practical knowledge of Japan’s regulatory requirements
• Project Management: Proficiency in planning, executing, and monitoring projects to ensure delivery
• Problem-Solving: Strong analytical skills with a proactive, risk-based approach to resolving
• Leadership & People Development: Ability to mentor and support team members, foster knowledge
• Communication: Excellent verbal and written communication skills in Japanese and business level in
• Compliance Orientation: Exceptional attention to detail with a robust understanding of regulatory