LEADERSHIP IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY
Leaders in the Quality Assurance and Regulatory Affairs departments influence and facilitate bringing products to market within the biotechnology industry. Focus on building communication among cross functional teams; exercising writing to specific audiences; and meeting internal and external customer needs and expectations. Explore and apply how quality and regulatory affairs skills are managed within diverse product and project teams.
Prerequisites & course information
Requisites: Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Summer 2026 Learning Outcomes: 1. Influence product and project vision from quality assurance and regulatory affairs standpoints. Audience: Graduate 2. Develop strategies to achieve organizational objectives. Audience: Graduate 3. Communicate effectively with colleagues, customers, and regulatory bodies. Audience: Graduate 4. Illustrate leadership principles and use ethical behavior in challenging and ambiguous situations. Audience: Graduate 5. Practice how diverse teams fit into organizational culture and successfully contribute from product development through submission, product launch, and post-market surveillance. Audience: Graduate Learning Outcomes: 1. Influence product and project vision from quality assurance and regulatory affairs standpoints. Audience: Graduate 2. Develop strategies to achieve organizational objectives. Audience: Graduate 3. Communicate effectively with colleagues, customers, and regulatory bodies. Audience: Graduate 4. Illustrate leadership principles and use ethical behavior in challenging and ambiguous situations. Audience: Graduate 5. Practice how diverse teams fit into organizational culture and successfully contribute from product development through submission, product launch, and post-market surveillance. Audience: Graduate
Sources
- Course catalogue ↗2026-2027