Certificate in Regulatory Affairs

Today it is essential that employees in the pharmaceutical, biotech, and medical device manufacturing companies - or related fields - understand the regulatory environment in which they work. Whether it's for better performance or career development, employees in these industries need to know how and why their products make it to the marketplace - or how and why they get rejected.

The Lehigh University Regulatory Affairs Certificate program has been developed for employees working in pharmaceutical, biotech, and medical device manufacturing companies who deal with regulatory and FDA issues in the workplace, those in the legal profession working with FDA law and regulations, and others interested in the field. Students will gain a general understanding of the Regulatory Affairs environment, a broader understanding of the FDA and how it works, FDA requirements covering the manufacture of drugs and vaccines, the risks and costs of non-compliance, and an understanding of the process, timetable and strategies used to get a product to market.

One must understand chemistry and chemical engineering in order to write the FDA-required protocols on pilot plant operations, on quality control assays, or on impurity profiles of the drug substances.