Abstracto

Recent and Future Developments in Regulatory Affairs

Han Sui

Regulatory Affairs (RA), often known as government affairs, are a career in the regulated industries of pharmaceuticals, medical devices, cosmetics, agrochemicals, energy, banking, and telecommunications. Within the healthcare industry, regulatory affairs have a very specific meaning (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs professionals (also known as regulatory professionals) are often in charge of the following general areas: •Ensuring that their businesses are in compliance with all applicable regulations and laws. •Collaborating with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, such as the Food and Drug Administration or the European Medicines Agency (pharmaceuticals and medical devices), the Department of Energy, or the Securities and Exchange Commission (banking). •Advising their companies on regulatory issues and the regulatory climate that may affect proposed activities specifically, addressing the "regulatory atmosphere" surrounding concerns such as prescription medication advertising and Sarbanes-Oxley compliance.