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Regulatory Affairs Specialists


Awareness of the need to monitor and inspect business activities and products increased in the 20th century. During this time government and industry regulatory organizations were established to protect the health and safety of the public and to prevent or reduce harmful effects on the environment. The U.S. Food and Drug Administration, for example, was established in 1906 to protect consumers from adulterated or misbranded food and drugs. This organization continues today to protect public health, ensuring that producers of food, drug, and tobacco products are in compliance with health safety laws and regulations.

The 1960s and 1970s brought about organizations like the Drug Enforcement Administration and the Environmental Protection Agency, which forced many industries and companies to change their business operations and behaviors or risk expensive fines and possible criminal charges. The Regulatory Affairs Professionals Society was founded in 1976, to provide support and standards for regulatory professionals involved in health care and related products. Based in Washington, D.C., this organization continues to provide education and certification programs to regulatory professionals, and has chapters and affiliates around the world.

In the late 1980s the National Society of Compliance Professionals was established, in direct response to various business violations that had come to public light, such as insider trading, the savings and loan crisis, and the procurement scandal in the U.S. Department of Defense. It was also during this time that the job of regulatory and compliance specialists and managers started to gain recognition. Companies started to create these positions to review, coordinate, and monitor their business practices, ensuring they complied with government and industry regulations.

Regulatory affairs specialists today work for many different types of companies, including banks, financial institutions, health care organizations, and federal and state agencies. Regulatory affairs specialists with current knowledge of existing and emerging regulations and laws and strong research, writing, and technology skills will continue to be in demand to help ensure companies' regulatory compliance.

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