COURSE CURRICULUM

The Pharmaceutical Regulatory Affairs and Quality Operations graduate certificate program is structured over two semesters and offers a combination of theoretical knowledge and practical experience to prepare students for careers in regulatory affairs, quality assurance, and pharmaceutical operations. In the first semester, students take courses including Biotechnology and Biopharmaceuticals, Product Formulation and Manufacturing, Introduction to Quality Assurance, Introduction to Pharmaceutical Regulatory Affairs, and Technical Writing and Communication I, all of which provide foundational knowledge of industry practices, regulatory frameworks, and quality management processes. The semester also includes a Work Term Preparation course to ready students for practical experience. An optional Work-Integrated Learning term, through RAQ441, allows students to gain hands-on experience in pharmaceutical regulatory affairs in a hybrid online and in-person setting. The second semester advances this foundation with courses such as International Regulatory Affairs and Harmonization, Introduction to Clinical Research, Pharmacoeconomics, Quality Assurance II, and Regulatory Affairs II, offering deeper exposure to global regulatory practices, clinical research, economic evaluation, and advanced quality management. The program is designed with flexible online delivery options to accommodate diverse learning needs. Overall, the curriculum integrates technical knowledge, regulatory understanding, and applied experience, equipping graduates to contribute effectively to the compliance, safety, and operational excellence of pharmaceutical and biopharmaceutical organizations.