Senior Associate or Manager, RA TA Group, Regulatory Affairs(Neurology)
AbbVieJob Description
📋 Description Execute regulatory affairs activities for assigned projects in Japan (e.g., NDA submissions, PMDA Collaborate with Clinical Development, PM/O and Commercial teams to provide regulatory input Lead regulatory strategies conforming to global and local requirements Interact with PMDA/MHLW and internal stakeholders to ensure compliance Monitor regulatory changes and communicate updates to teams Support development/maintenance of regulatory SOPs and best practices 🎯 Requirements Regulatory knowledge of Japan regulatory requirements Teamwork and cross-functional collaboration Project management across multiple initiatives Problem-solving with regulatory and operational issues Strong Japanese communication; business-level English Attention to regulatory detail and compliance 🎁 Benefits AbbVie career development in a global pharmaceutical environment Opportunity to contribute to neuroscience, immunology, and oncology programs Collaborative, cross-functional team culture