Compliance

• Contribute to the development and implementation of regulatory strategy for specific projects
• Serve as the regulatory representative from Japan on relevant project teams
• Serve as regulatory contact with relevant regulatory authorities
• Manage preparation of submission documents and approval of new drugs, including life cycle management in Japan
• Lead development, alignment, and implementation of Japan regulatory strategy across all development stages
• Provide end-to-end leadership for regulatory submissions in Japan
• Lead meetings and interactions with Japanese Health Authorities
• Translate authority feedback into actions and strategic recommendations
• Identify, assess, and communicate regulatory risks and opportunities
• Develop mitigation and escalation strategies
• Provide recommendations balancing regulatory compliance with risks and benefits of innovative approaches

Compliance jobs in Japan

Senior Manager, Regulatory Affairs