Job Title
Director, Regulatory Affairs – Gene Therapy (Japan)
Role Overview
Lead regulatory strategy and execution for gene therapy products in Japan. Ensure compliance with local regulations, guide development programs, manage submissions, and align Japan regulatory plans with global strategies.
Key Responsibilities
Serve as the regulatory lead in Japan for gene therapy projects
Develop and communicate Japan-specific regulatory strategies and risk assessments to internal teams and leadership
Collaborate with global and cross-functional teams (Clinical, CMC, QA/QC, Nonclinical, etc.)
Oversee preparation, writing, and submission of documents to PMDA/MHLW
Lead meetings and discussions with Japanese health authorities
Monitor regulatory issues, risks, and competitor activities in Japan
Review regulatory-related documents (clinical, CMC, etc.) to ensure compliance with Japan requirements
Ensure timely, high-quality submissions and lifecycle management
Manage external consultants and vendors as needed
Track new regulations in Japan and update internal teams accordingly
Mentor junior regulatory staff and promote a strong compliance culture
Requirements
Extensive experience in gene therapy and/or rare diseases in Japan (preferred)
Strong knowledge of biologic drug development and Japanese regulatory requirements
Proven experience leading regulatory strategy and interactions with health authorities in Japan
Hands-on experience preparing regulatory submissions in Japan, including CTNs and lifecycle documents
Familiarity with eCTD and ICH guidelines
Bachelor’s degree in a scientific discipline (advanced degree preferred: Master’s, PhD, PharmD)
10+ years of regulatory affairs experience in Japan for biologics (5–7 years in gene therapy desirable)
Experience with J-NDA and regenerative medicine submissions preferred