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Competition within the Regulatory Marketplace

by Hazel Grace
in Business
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Countless products today undergo security checks before they reach the public. In fact, the FDA reports that 25 cents of every dollar go to buying a product that is regulated. Companies specializing in regulatory affairs must ensure they have the right talent in place, as this job is crucial to keeping consumers safe.

However, finding this talent remains an issue for many organizations. For this reason, many companies today turn to a regulatory affairs executive search firm to help in finding candidates for each open position. For more information on how these firms can help, get more details from ERAPS.

What do Regulatory Affairs Specialists Do?

A regulatory affairs specialist helps the employer comply with all laws and regulations that apply to the products they produce. In many cases, these individuals work in the pharmaceutical and biotech industries. These individuals interact with regulatory bodies and government officials. In addition, they may work for a regulatory agency. The tasks these specialists do vary by which industry they work in and the size of the employer.

Government Interference

On July 9, 2021, President Biden signed an executive order addressing competition in the American economy. This order addressed excessive market concentration in certain industries. The purpose of this order was to increase competition in those industries by enforcing antitrust laws.

The Effect of the Executive Order

Many experts believe the order reduced mergers and acquisitions. According to these experts, mergers and acquisitions enhance competitiveness while helping companies compete on a global scale. In addition, a merger or acquisition can actually improve the efficiency of the companies. However, the executive order and rulings by the Federal Trade Commission have left many organizations hesitant to take this step.

What is Included in the Order?

Following this executive order, states and tribes will now be permitted to purchase prescription drugs from Canada. The Health and Human Services Administration (HHS) is directed to increase support for generic and biosimilar medications. This will provide consumers with low-cost alternatives to expensive prescription drugs. However, there are only two of the new requirements put forth in the executive order.

The order also directs HHS to find ways for hearing aids to be sold over the counter. Competition remains scarce in this industry, and millions of Americans cannot afford hearing aids today. The order looks to change this.

This order also addresses hospital mergers and their effect on patients. It discusses hospital transparency pricing rules and surprises hospital billings. Furthermore, the order looks to standardize health care plans offered on the National Health Insurance Marketplace. This will make it easier to help consumers compare the different plans.

How Regulatory Affairs Specialists Can Help

Every biotech and pharmaceutical company needs to ensure they remain in compliance with this executive order and all laws and regulations. Regulatory affairs specialists ensure they do. If a company is struggling to fill open positions in this department, it needs help. Open positions can lead to delays in research and development, the release of new products, and more.

Turn to an executive search firm specializing in these industries to help in finding the right talent for open positions. When searching for this talent, the search firm considers the key regulatory requirements of that position. In addition, they take into account whether a candidate will align with the culture of the company.

When they find a person that meets the requirements and aligns with the culture, the company in need of new talent is informed. They can then interview this candidate and possibly fill the position. This benefits all, as delays in these industries can be a matter of life and death.

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