3. What is Regulatory Affairs?
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, specifically pharmaceuticals, medical devices, and diagnostics products within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals
Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:
Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals) and Notified bodies (medical devices).
Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs.