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

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