Pharma Knowledge Initiative


Core Competency

  • 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