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.