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
