If you’ve been following the rapid development of Covid-19 vaccines in recent months, you were also following a critical moment in the evolution of regulatory affairs and seeing firsthand how the discipline affects our daily lives. While regulatory affairs is a relatively new field, its importance to society’s health, safety, and well-being has never been more visible. Beyond the development of safe vaccines and pharmaceuticals, regulatory affairs is a growing career path within multiple industries, including food and nutritional products, medical devices, cosmetics, biologics, in-vitro diagnostics, and veterinary products.
“2020 has put a new light on how important the regulatory process is,” says David Mahoney, assistant teaching professor of Northeastern University’s Master of Science in Regulatory Affairs program. “It’s not just about getting a product to market. It’s ensuring that the product is safe. The current example of vaccine development has amplified the underlying feeling within our population that anything going into our system must be both safe and effective.”
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What Do Regulatory Affairs Managers Do?
In its broadest sense, Mahoney describes the role of a regulatory affairs manager as ensuring compliance that enables the delivery of safe products to consumers. More specifically, the job’s components include planning, leading, and facilitating a company’s product development and production process to align with current regulations and operating procedures. This can include state, federal, and international compliance, depending on distribution and the markets served. The job consists of direct interaction with regulatory agencies and bodies, like the U.S. Food and Drug Administration (FDA), that are involved at different points of the product timeline.
Regulatory affairs managers also may be responsible for:
- Being fully up-to-date on all related regulations, including proposed changes and their implications for the company’s products
- Communicating regulatory requirements throughout their organization
- Ensuring regulatory applications, documents, and reports are thorough, complete, and delivered on time
- Proactively developing strategies for their companies to meet or exceed requirements while meeting business goals and objectives
- Launching new products and modifying existing products as regulations evolve
- Leading efforts related to any product recalls
Regulatory Affairs Managers Come From Varied Backgrounds
If your professional goals include working within a stable, high-potential field with ongoing opportunities for advancing your career, regulatory affairs should be on your radar. Within the career path, a regulatory affairs manager role is one of the most aspired-to positions. Surprisingly, the title is broad in scope and responsibility. It’s common for a company to have multiple people in the role—all with different specialties and areas of focus. “Regulatory affairs pulls from multiple backgrounds. The field includes individuals with research expertise, while others bring administrative, legal, and analytical skills,” Mahoney says. “A regulatory affairs manager isn’t a superhero that has it all, but they must be able to communicate effectively with a team.”
“Working within regulatory affairs and moving up to a management position, students with an interest in related product categories from pharmaceuticals to food have excellent career potential,” Mahoney continues. “Many students and professionals are not aware of the field and its opportunities. The reality is that compliance requires a broad skill set. Even though about 50 percent of the applicants to our graduate program come from the life sciences, the mix is changing to include more people with an interest in law, business, and management. It’s a growing field with a high demand that offers people a great living.”
What Makes a Regulatory Affairs Manager Successful?
“Success involves an individual’s ability to help others in their organization understand all compliance requirements and how to meet them,” Mahoney says. “They also ensure the company adapts to the inevitable changes which occur through time. A great regulatory affairs manager sees all the moving pieces and is able to communicate with internal partners that may have conflicting needs and goals. Regulatory affairs managers may move into their role with a background in one area, but they develop a fluency across multiple areas and specialties.”
What Kind of a Degree Do I Need?
According to the Regulatory Affairs Professionals Society’s (RAPS) 2020 Compensation & Scope of Practice Survey, nearly 64 percent of respondents have a postgraduate degree, including 22 percent with a doctorate. While an advanced degree is not an absolute must-have, the RAPS survey shows that a master’s degree opens doors within the field.
“For student’s considering this path, the Northeastern University’s Master of Science in Regulatory Affairs degree provides significant advantages,” Mahoney says. “Our faculty has a wide variety of backgrounds and industry expertise, and the curriculum continuously adapts to include developing areas of industry. Northeastern has a large alumni program that provides students with the ability to explore new opportunities and build a lifelong professional network. The University also has a historical leadership role in experiential education, and most regulatory affairs students fully leverage the ability to build professional experience into their degree. This gives students a foot in the door that can really accelerate placement.”
What do Regulatory Affairs Managers Earn?
The RAPS survey shows that regulatory affairs managers earn an average total compensation of $138,000, which can surge to $213,000 at the director level. The survey indicates that respondents in New England and Pacific states tend to report the highest compensation.
Aside from the financial rewards, survey results also show that nearly 81 percent of regulatory affairs managers feel valued and recognized by senior management and executives. The vast majority of respondents found ensuring healthcare products’ safety and effectiveness to be an ongoing motivator. They also place a high value on the job security that the field provides.
“In talking with graduates from the Northeastern master’s program—and from my own perspective—it is incredibly rewarding to be part of a group that enables the progress of mankind, whether it be creating a safe food supply chain, medical care that sustains life, or innovative pharmaceuticals,” Mahoney says. “Regulatory affairs brings safe solutions to our biggest issues.”
The outlook for jobs within the regulatory affairs sector is expected to remain on an upward trajectory. The U.S. Bureau of Labor Statistics estimates that positions within regulatory affairs will continue to grow at an average of eight percent through 2026.
Explore Your Next Steps
If you’re interested in embarking on the path to becoming a regulatory affairs manager, a fulfilling career awaits. Your next step should be taking a closer look at the best educational path to get you where you want to be. It’s a personal choice, and there are different approaches to set yourself up for success.
To learn more about advancing your career in regulatory affairs, download our free guide below.