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.