Seniro Associate or Manager, RA TA Group, Regulatory Affairs(Neurology)

📋 Description Execute regulatory affairs activities for assigned projects in Japan. Prepare and submit regulatory documents to PMDA/MHLW (e.g., NDA, consultations, CTFs). Collaborate with cross-functional teams to provide regulatory input throughout product life-cycle. Lead regulatory strategies, aligning global and local requirements. Monitor regulatory changes and communicate updates to teams. Support development and maintenance of regulatory SOPs and best practices. 🎯 Requirements Regulatory knowledge of Japan’s requirements and procedures. Strong teamwork and cross-functional collaboration. Project management: handle multiple projects and deadlines. Problem-solving with proactive issue resolution. Effective communication in Japanese; business-level English. Attention to regulatory detail and compliance. 🎁 Benefits Company-competitive benefits package. Opportunities for professional growth in regulatory affairs. Collaborative, multi-disciplinary work environment. Global to local regulatory exposure, with ongoing process improvements.