Certificate in Regulatory Affairs

1. Bachelor’s degree from a recognized institution
2. Background in life sciences, pharmacy, medicine, biotechnology, engineering, or healthcare preferred
3. Professionals working in regulatory affairs, clinical research, pharmaceuticals, or medical devices encouraged to apply
4. Statement of Purpose required
5. Resume or Curriculum Vitae
6. English language proficiency for international applicants (if applicable)

The Regulatory Affairs Certificate at the University of Pennsylvania is designed to prepare professionals for regulatory roles within the healthcare, pharmaceutical, biotechnology, and medical device industries. Delivered through the Perelman School of Medicine and affiliated regulatory science programs, the course provides comprehensive knowledge of regulatory policies, compliance requirements, and approval processes. Learners gain understanding of U.S. and international regulatory agencies, including FDA-aligned frameworks. The curriculum emphasizes practical regulatory documentation, ethics, and risk management. Faculty include experts with academic and industry experience in regulatory science. Real-world case studies strengthen applied learning. Graduates are equipped to support regulatory submissions, compliance activities, and strategic decision-making in regulated healthcare environments.