Take a regulatory writing course from the PDP. Clinical documents discussed include clinical trial protocols, clinical trial informed consents (ICFs), investigator brochures (IBs), and clinical study reports (CSRs) among others.
Regulatory Affairs professionals work at the interface of industry and government to help ensure that biomedical technologies are safe, effective, high quality, and correctly labeled and marketed. You will help protect the public by evaluating the safety and efficacy of healthcare products before and after commercial release.
Interested in Regulatory Affairs? Check out our overview of this career at the link below for more information on this career and the skills you will need to succeed.
Learn more about the following careers:
Gain Skills and Experience
The Regulatory Affairs Certification (RAC) is the only certification specifically for regulatory professionals in the healthcare product sector, which is obtained by passing a rigorous exam. Learn the regulations that apply to drugs, biologics or medical devices.
Complete online tutorials, classes or internships at the FDA.
Sign up for FDA updates on regulation changes.
Familiarize yourself with regulatory guidelines.