Tokyo Sandoz

Job Description

  • Review and evaluate non-clinical/ clinical data
  • Plan clinical development strategy with assistance from manager and global team
  • Prepare documents for PMDA consultation in collaboration with local regulatory affairs and global team
  • Execute and report bioequivalence studies, pharmacodynamic studies and clinical endpoint studies with healthy subjects and patients in accordance with GCP and other regulatory requirements with assistance from Manager
  • Vender Management with assistance from manager
  • Prepare submission dossier non-clinical and clinical part with assistance from manager and global team
  • Prepare answers to deficiency letters from PMDA with assistance from manager and global team
  • Management and archive relevant documents
  • Support market team after getting approval with assistance from manager


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