Manager II, 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

• Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public
• Substantial experience in regulatory affairs within the pharmaceutical or healthcare industry
• Extensive project experience in new drug development and life-cycle management, with demonstrated
• Experience guiding or mentoring junior team members and contributing to team or functional