What It Is Like to Work In Regulatory Affairs

Typically, when one earns a degree in a health care-related field, such as health care administration or nursing, they expect to go work within a health care setting that provides direct care to patients. Some go on to work for insurance or pharmaceutical companies, or in another related field, but in general, there are certain expectations for one’s career path.

However, there’s another option that’s often overlooked, but is vital to the function of any health care system. Regulatory affairs connects business and the government, ensuring that the products and services provided to the public are safe and effective, and developed and marketed in compliance with the rules and standards as established by the government.

Regulatory affairs professionals stand at the crossroads between business and government, and must have a keen understanding of not only their employers’ business interests but also the rules and laws governing that business, as well as the scientific principles.

In fact, many people assume that one must be a scientist, or at least have a science-related degree, in order to work in regulatory affairs. After all, they must be able to translate the complex scientific principles of a new device, medication, or procedure, as their work often extends from the research and development phases through monitoring performance after a product is brought to market. However, while scientific knowledge is certainly important, working in RA actually requires other skills that are just as, if not more, important, and often gained through a regulatory affairs degree and training programs.

Attention to Detail Is Job One

Bringing a new health care product to market, whether an advanced device or a nutritional product, and everything in between, is a complex process. Companies are bound by strict regulations designed to protect consumers — regulations that can require several thousand pages of documentation before anything can be approved for sale.

A regulatory affairs professional, then, is responsible for making sure that not only are those thousands of pages perfect, but that the entire development process complies with governmental regulations. For that reason, some liken RA professionals to police officers: They are often lurking around the corner, looking for rule breakers and violations that need to be fixed, or otherwise telling everyone else what they cannot do. This is accurate to some extent, since the RA pro’s job is essentially to save the company’s development team from themselves. However, their responsibilities go well beyond preventing cut corners or administrative oversights.

Most experts point out that regulatory affairs professionals should become evangelists. That is, they should not only be able to cite regulations and identify potential pitfalls at 20 paces, but also be willing to serve as a part of the team and share their regulatory knowledge. The most successful professionals are those who can work with all constituents and train them to identify their own errors or potential issues, and correct them before they become a larger issue. While no one else in the organization is likely to be as detail-oriented or familiar with the rules and regulations as the RA team, with the expert guidance and communication of the RA professionals, the entire company can strive toward a culture of compliance and avoid unnecessary delays and other issues.

But What Does a Regulatory Affairs Professional Actually Do?

As with any field, specific job descriptions vary, but many regulatory affairs positions include:

  • Managing the process of regulatory applications to various federal agencies.
  • Staying up-to-date with current regulations, as well as proposed and changing rules.
  • Developing strategies to ensure that new products are approved by the government.
  • Assisting with the development and implementation of compliant marketing plans.
  • Engaging in post-market surveillance of products.
  • Providing training in regulatory issues.
  • Providing regulatory input into product development and corporate policies.

Again, above all, working in regulatory affairs requires an exacting attention to detail in addition to an understanding of the regulations governing the industry. A single error — or even a misguided word choice — can lead to delays, further investigation, or even denial or regulatory action.

Of course, while regulatory affairs is a challenging field, it’s also a rewarding one. Entry-level positions tend to pay between $55,000 and $77,000 per year, while advanced executives often earn around $200,000 per year. Thanks to increased regulation in the health care industry both at home and abroad, the number of RA positions is expected to increase in the next few years, meaning that if you have an interest in helping shape the future of health care, while putting your passion for details to work, this could be an ideal career choice.

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