Mission and Learning Goals
The goal of the Master of Professional Studies in Regulatory Affairs program is to provide students with the strategic vision, skills, and tools required to address regulatory requirements in all stages of the product lifecycle, including pre-clinical and clinical research, product development, manufacturing, post-market obligations, and labeling/promotion.
Students who successfully complete the master’s in Regulatory Affairs will:
- Gain a comprehensive understanding of the primary philosophies, theories, and practices of the regulatory affairs profession in the areas of drugs, medical devices, and biologics, including the requirements surrounding clinical research.
- Develop proposal strategies to enable sponsors to bring medical products to US and international markets..
- Prepare regulatory documentation to demonstrate compliance of medical products with applicable U.S. and international laws and regulations.
- Develop the skills and abilities used to assess and improve manufacturing practices in the medical industry.
- Operate effectively within the regulatory environment in the United States and in select countries in Europe and Asia.
- Develop the skills and abilities necessary to ensure that clinical research and human experimentation are ethically conducted and comply with relevant laws.
- Develop oral and written communication skills that enable organization and presentation of data in a concise manner for internal and external stakeholders, including regulatory authorities in both domestic and international markets.
- Cultivate specialized knowledge, skills, and abilities relevant to regulatory labeling, regulatory submissions, strategic planning, and pharmacovigilance.