Student who successfully complete the Master of Science degree in Regulatory Affairs should be able to do the following:
- Interpret existing United States healthcare-related laws, regulations, guidelines, guidances, and policies pertaining to the development of pharmaceutical and medical device products;
- Evaluate the multifaceted research and development process for pharmaceutical, biologic and medical device products from an FDA regulatory perspective;
- Assess the impact and identify critical areas of compliance with quality-related regulations and policies, e.g., Good Laboratory Practices, Good Clinical Practices and current Good Manufacturing Practices, for research, development, manufacture and commercialization of regulated healthcare products;
- Interpret the impact of FDA-related laws and regulations on activities of other key areas of research and development, e.g., clinical research, quality control, quality assurance, and validation;
- Identify the key specific areas of responsibility of the regulatory affairs professional that extend throughout the lifetime of each healthcare product;
- Research and identify international healthcare regulations and apply them in the planning of a pharmaceutical or medical device development program;
- Utilize effective communication skills based on organizational behavior and project and operations management principals within a project development team environment in the pharmaceutical, biotechnology and medical device industries;
- Interpret, summarize, and explain requirements for FDA submissions to test investigational drugs, biologics, and medical devices with human subjects; and
- Interpret, summarize, and explain the main sections of a new drug application, a biologics license application, and a premarket application and notification