Student who successfully complete the Master of Science degree in Regulatory Affairs should be able to do the following:
- Identify, research, interpret, and apply laws, regulations, guidances, and policies pertaining to the research and development of biologic, pharmaceutical, and medical device products;
- Identify and navigate the steps in the development process for pharmaceutical, biologic, medical device, and combination products;
- Articulate related regulations and effectively address health agency concerns and communications related to preclinical, quality, and clinical;
- Identify the key specific areas of responsibility of the regulatory affairs professional that extend throughout the lifetime of each healthcare product;
- Demonstrate effective oral, written, and visual communication skills to convey appropriate information to internal and external audiences with differing knowledge and priorities;
- Interpret, summarize, and explain requirements for regulatory submissions to test investigational biologic, pharmaceutical, and medical device products;
- Interpret, summarize, and explain the main sections of a marketing application for biologic, pharmaceutical, and medical device products;
- Identify and support the wide variety of regulatory activities involved with the maintenance of an approved marketing application; and
- Demonstrate leadership and strategic thinking by contributing to transdisciplinary teams that support quality improvement and business development.