- Working Knowledge in Regulatory Strategy development
- End -to -End Regulatory Tracking and Process Management
- Lean Product Development and Commercialization Process Management
- Regulatory Risk Assessment for Registration
- Competitors Analysis
- Identify and validate relevant guidelines for starting Japan Operations
- Expertise in writing and reviewing Japanese Regulatory Documents
for clinical trial and NDA - Willingness & flexibility to accept new concept
- Proactive problem solving ability
- Communicative Competency in both Japanese & English