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Regulatory Affairs Managers


It was in the 20th century that awareness of the need to monitor and inspect business activities and products increased. 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. One example is the U.S. Food and Drug Administration, which was established in 1906 to protect consumers from adulterated or misbranded food and drugs. Today the organization continues 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 were being exposed to the public at that time, such as insider trading, the savings and loan crisis, and the procurement scandal in the U.S. Department of Defense. It was also in the late 1980s that the job of regulatory and compliance managers started to take root as a recognized profession. Companies started to create these positions to review and monitor their business practices, to make sure they were in compliance with government and industry regulations.

Regulatory affairs managers today work for companies large and small, from consultancies and organizations with 10 employees to global corporations with thousands of employees, including banks, financial institutions, health care organizations, and federal and state agencies. Companies will continue to rely on regulatory affairs managers' knowledge and skills to help keep their products and business operations in compliance with government and industry regulations, and to maintain their integrity and good reputation in the public eye.

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