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Regulatory Strategy for Drug Development, Progam Management and Leadership

  • Evaluate, develop, and monitor regulatory strategy for drug development
  • Prepare and manage product development plans, to include identification of critical tasks, preparation and maintenance of project timelines, oversight and technical expert coordination
  • Project reporting to team members, senior management, and Board of Directors
  • Conduct due diligence assessments for acquisitions and other investment decision-making to ensure that regulatory strategy for drug development meets FDA requirements
  • Provide advice on Orphan Drugs Designation, Fast Track, Breakthrough Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions as they relate to biological products
  • FDA regulatory affairs services for regulatory options and development pathways