Head of Regulatory Affairs, Development – Biopharma

Role Overview

Lead Japan Regulatory Affairs activities for development programs, from development through approval and lifecycle management, in collaboration with global and local stakeholders.

Key Responsibilities

• Lead and develop the Japan Regulatory Affairs Development team, including coaching, mentoring, and performance management.
  
• Develop and execute Japan regulatory strategies aligned with global development plans.
  
• Lead interactions with Japanese Health Authorities, including PMDA and MHLW.
  
• Lead Japan NDA and supplemental application activities, including indication expansions and formulation changes.
  
• Oversee preparation of Japan regulatory submissions, including CTD Module 1 and related documents, and manage the Health Authority review process through approval.
  
• Lead Japan labeling and electronic Package Insert (J-PI) activities, including Health Authority responses and review of promotional materials.
  
• Manage external regulatory vendors and contribute to SOP, process, and operational improvements.
  
• Identify and manage regulatory risks and provide strategic advice to cross-functional project teams.
  

Requirements

Key Qualifications

• Extensive Regulatory Affairs experience, particularly in drug development and Japan regulations.
  
• Strong experience with PMDA/MHLW interactions and Japan regulatory submissions.
  
• Proven people leadership and cross-functional/global collaboration experience.
  
• Strong stakeholder management, communication, strategic thinking, and project/risk management skills.
  
• Native-level Japanese and business-level English.