Manager, RA TA Group, Regulatory Affairs(Neurology)

📋 Description

• Execute regulatory activities including prep/submission of documents to PMDA/MHLW.
• Collaborate with cross-functional teams to deliver regulatory input through the lifecycle.
• Lead and implement regulatory strategies, considering global and local requirements.
• Interact with PMDA/MHLW and internal stakeholders to ensure regulatory compliance.
• Monitor regulatory changes and communicate updates to relevant teams.
• Support development and maintenance of regulatory SOPs and best practices.

🎯 Requirements

• Solid understanding of Japan regulatory requirements.
• Strong teamwork and knowledge sharing.
• Project management across multiple projects with deadlines.
• Problem-solving for regulatory and operational issues.
• Communication in Japanese; business English for cross-functional work.
• Compliance orientation with regulatory frameworks.

🎁 Benefits

• Equal opportunity employer committed to diversity.
• Supports employees with disabilities.