Career Spotlight: Regulatory Affairs Specialist

How to Start a Career in Regulatory Affairs

What Is a Regulatory Affairs Specialist?

Regulatory affairs is a unique industry directly related to the Food and Drug Administration (FDA). If you’ve ever used makeup products, taken prescription drugs, or eaten a bag of chips, those products have gone through rigorous regulatory checks before people are able to use them. In addition to its role in the food and drug industry, regulatory affairs extends to medical technologies, including medical equipment, biotechnological advances, and implanted devices. This is to ensure all products and machines are safe, efficient, and perform the way they are supposed to before they can be purchased or used by the public.

A regulatory affairs specialist can work in a number of industries to make sure regulations are met at all levels. At the state, federal, and international levels, there are many regulations to ensure products, food, and drugs are safe to use or consume. However, with the increased accessibility of food from around the world and the rapid development of new technologies, new risks are introduced almost daily. Because of this, regulatory affairs specialist positions are increasing across the globe. Demand is expected to increase 88 percent by 2029.

What Does a Regulatory Affairs Specialist Do?

The job duties of a regulatory affairs specialist vary depending on the industry in which they work. Check out some of the most common responsibilities:

● Stay up to date with new and existing regulations that may impact an organization’s products and processes.
● Standardize all business operations to establish clear and documented protocols.
● Maintain data and files of all regulations.
● Create marketing, legal, and technical documents to ensure compliance.
● Work with other employees to ensure their knowledge of regulations, procedures, and policies are accurate.
● Research and recommend courses of action to help a company achieve the necessary levels of compliance.
● Report on compliance status to internal and external parties.
● Act as a liaison between an organization and state, local, and federal agencies.

Regulatory affairs specialists are also brought in early in product development process to ensure compliance at each step. This includes monitoring the research and development of a product, creating and manufacturing the product, marketing the product, and final approval.

Why Are Regulatory Affairs Specialists Needed in Nutrition?

The nutrition field must stay up to date with research and compliance to be successful. People need to trust that what they read on food labels and what they hear from nutritionists and dieticians are correct. Regulatory affairs specialists help to make this possible by continuing to build trust between the nutrition world and the general public.

Regulatory affairs specialists can help to regulate food under the current protocols set forth by monitoring serving sizes, what goes into processed foods, and much more. They are responsible for making sure all food that can be purchased by the public is compliant, assuring the public that food is safe to consume.

How to Get into Regulatory Affairs

Many regulatory affairs positions are considered entry-level and will give you a deep understanding of the field. A bachelor’s degree in health sciences, public health, biology, or another related discipline is a great step toward working as a regulatory affairs specialist. As the field grows, organizations are looking for applicants who have a graduate degree as well. The Graduate Certificate in Nutrition at Excelsior College will set you up for a successful career in this field, especially if you are interested in the food and drug industry. Besides education, other important factors to become a regulatory affairs specialist include the following:

● Work experience. Hands-on experience is key to moving up the ladder.
● Continuing education and professional development. Due to the constant changes in this field, it is critical that people in the regulatory industry stay up to date.
● Your network. Knowing the right people in this industry can have a huge impact on your career. Make sure to network, connect with other professionals, and continue looking for career advancement opportunities.

On average, regulatory affairs specialists earn $74,663 per year in the United States. A regulatory affairs specialist can earn well over $100,000 per year, depending on the state or industry. If you are passionate about what goes into your products, food, and drugs, a position as a regulatory affairs specialist might be the right fit for you!