The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more. According to the FDA, 25 cents out of every dollar that Americans spend each year is spent purchasing a regulated product.
The ubiquity of regulatory work makes it an ideal field for anyone interested in using scientific methods and analysis to make a difference in the world around them.
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry. Here, we explore the role and responsibilities of regulatory specialists, including working conditions and essential skills, as well as advice and tips for advancing in a regulatory career.
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What is a Regulatory Affairs Specialist?
A regulatory affairs specialist is someone who works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. Most often, they work in the food and beverage, pharmaceutical, and medical devices industries, though many other companies—such as those that produce automotive or mechanical components, and even financial services—also require regulatory compliance.
Because most regulatory affairs specialists (76 percent, as of 2016) work directly in a regulated industry, most routinely interact with regulatory bodies and government agencies. Some of these professionals work directly for those regulatory agencies, including the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC), among others.
A regulatory affairs specialist’s duties depend on a number of factors. The most important of these factors is the specific industry being worked in, as each industry is bound to its own set of regulations.
The responsibilities of these professionals also depend on the size of the organization. Regulatory specialists working for larger organizations may have a more narrowly-defined role compared to those who work at smaller organizations because larger organizations tend to have larger regulatory affairs offices or teams. A more focused role allows for increased specialization compared to organizations with smaller teams, which may require more flexibility from workers.
Some of the most common tasks and responsibilities of regulatory specialists include:
- Maintaining a deep understanding of new and existing regulations that may impact their organization’s products and processes
- Using that understanding to standardize all business operations and establish clear, documented protocols
- Explaining regulations, procedures, and policies to all employees and stakeholders as necessary
- Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency
- Reviewing marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance
- Recommending courses of remediation to help their company achieve the necessary levels of compliance
- Implementing internal audits of products and protocols to identify areas of weakness, and putting in place corrective measures
- Regularly reporting on compliance status and measures to both internal and external parties
- Preparing for and facilitating third-party audits as necessary
- Acting as a liaison between their organization and state, local, federal, and international agencies to submit required forms and paperwork
In addition to the responsibilities listed above, regulatory specialists are also often leveraged at various stages throughout the product development process to ensure compliance every step of the way, from research and development through manufacturing, marketing, and final approval.
If you’re interested in becoming a regulatory affairs specialist, developing the right skills can help. These include:
- Attention to detail: By nature, the work expected of a regulatory affairs specialist can be rather regimented, requiring that particular processes and protocols be followed at all times. That’s why attention to detail is so critical: One misstep can put lives and the organization’s reputation at risk.
- Analytical skills: While regulatory affairs specialists are not analysts, collecting and analyzing data to identify patterns and potential liabilities is still often a part of the job description for many.
- Communication skills: While regulatory expertise is essential to working in regulatory affairs, it’s useless if you cannot effectively communicate with those around you, whether they be coworkers, team members, vendors, or customers.
- Project management: Regulatory affairs is, in many regards, very similar to project management, requiring the planning and coordination of many moving pieces to achieve the desired result. (This is especially true during the development and launch of new products and services.) Therefore, skills like project and time management are essential.
- Domain expertise: To be effective in the role, a regulatory affairs specialist must be an expert in the domain of their company or organization. This means having a deep understanding not just of the products or services offered by the company, but also of the broader industry in which the company operates and the agencies that regulate it.
- Sense of mission: The best regulatory affairs specialists—those that truly make a difference—do not simply see regulatory affairs as a job. They understand the importance of their role in protecting consumers from danger and are compelled by this mission to reduce harm.
If you’re interested in working in regulatory affairs, becoming a regulatory specialist is a great way to break into the field.
Generally speaking, these positions only require applicants to have earned a bachelor’s degree in a related field (product safety, biology, chemistry, and other sciences are popular fields). In exchange, specialists enjoy a competitive average salary of around $57,000, though this can reach as high as $85,000 depending on the industry and company.
While it is possible to gain an entry-level position with as little as a bachelor’s degree, according to the 2016 Compensation & Scope of Practice Report produced by the Regulatory Affairs Professionals Society (RAPS), 42 percent of employers prefer regulatory candidates who hold a graduate degree, and 45 percent of specialists hold a master’s degree.
Education levels become even more important as individuals move into more senior level positions, as these roles typically require a much deeper level of experience and understanding. According to the same RAPS report referenced above, graduate-level education is commonplace amongst senior professionals in the regulatory affairs industry. Forty-three percent of all vice presidents, 46 percent of all managers, and 40 percent of all directors hold at least a master’s degree.
It’s for this reason that many who wish to advance within the field will choose to pursue a graduate degree related to their industry—for example, a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices or Food and Food Industries.
Other important factors that can impact the trajectory of your career in regulatory affairs include:
- Experience: As in most fields, real, hands-on experience is critical for those hoping to advance in their careers. In the regulatory affairs industry, most VPs have an average of 19 years in the industry, directors have an average of 14 years, and managers have an average of 10 years. Taking every opportunity that you can to gain a wide variety of working experience—including internships and hands-on projects—can have major impacts on your career.
- Continuing education: Because the regulatory affairs industry is rapidly evolving as new regulations and technologies are created, it’s critical that regulatory professionals stay abreast of the latest developments affecting the industry.
- Network: Who you know in the industry can have a major impact on your career. Joining an organization like RAPS or The Organization for Professionals in Regulatory Affairs (TOPRA) can offer many networking opportunities, as can leveraging the professors and alumni from your degree program.
If you’re considering pursuing a career in regulatory affairs, including the skills and education required to get ahead, download our free guide below.