[Japan] Associate Manager, Global Regulatory Operations & Maintenance

Lead high-quality regulatory submissions for Asia-Pacific markets (excluding China and Japan), managing clinical, non-clinical, and CMC documentation. Consolidate responses to regulatory inquiries and drive rapid approvals for new filings, updates, and variations. Manage regulatory requirements and ensure compliance across the full product lifecycle in assigned markets. Monitor global regulatory trends to propose appropriate responses and oversee regulatory activities spanning multiple products and regions. Coordinate effectively with internal departments, overseas sites, and external partners to advance regulatory operations. Continuously improve regulatory processes and provide guidance to stakeholders.