Job Description
Position Summary:
The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners to ensure compliant and timely change controls. This role involves evaluating CMC and related changes, determining regulatory pathways, defining data needs, and managing submissions such as partial and minor changes, notifications, and consultations. This role supports lifecycle management and works cross-functionally to maintain business continuity and compliance. A strong knowledge of Japanese pharmaceutical regulations, change control, CMC, quality concepts, and company procedures is essential to provide regulatory advice, risk assessment, and coordination for marketed products.
Key Accountabilities:
- Post-Approval Regulatory Change Control Strategy and Execution for Marketed Products
- Regulatory Co...