Whether you realize it or not, you cross paths with the regulatory affairs industry on a daily basis. In fact, 25 cents of every dollar spent by American consumers go toward a product or service regulated by the Food and Drug Administration (FDA). Each food, beverage, cosmetic, prescription medication, or vitamin you purchase has undergone rigorous regulatory checks for safety and efficacy on its path to supermarket shelves.
But it’s not just food and prescription drugs that need to be approved for human consumption. All medical technologies, including medical equipment, implanted devices, and biotechnological advancements, are also subject to federal and international regulation to ensure their safety, efficacy, and performance.
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Despite these stringent regulations, the rapid development of new medical technology and the increasing accessibility of food from around the globe introduce new risks to the market daily. Thus, it is now a global imperative to develop and improve state, federal, and international regulations to maintain the innovation and release of food and biomedical products to global markets. To do this, we rely on the expertise of regulatory professionals.
Are you interested in gaining this expertise and breaking into a growing industry? Here’s an overview of the regulatory affairs industry, including careers and trends, to help you navigate the field.
What Is Regulatory Affairs?
The regulatory affairs industry oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.
Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world. But what do these professionals actually do on a daily basis?
What Do Regulatory Affairs Professionals Do?
According to Dr. Stephen Amato, associate teaching professor and lead faculty member for Northeastern’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program, the answer is, “It depends.”
Because the field of global regulatory affairs spans a diverse set of disciplines, including law, economics, public policy, health, and science, the scope of a regulatory professional’s work varies. Career paths and daily responsibilities may differ based on areas of expertise, but all regulatory professionals have one goal in common: to facilitate the commercialization of safe and effective products and services. Some regulatory affairs professionals manage clinical studies or develop marketing approval policies, while others design labels for food- and drug-related products. Many regulatory professionals carry titles such as regulatory affairs manager, food safety inspector, clinical research associate, or director of quality assurance.
One of the most common titles in the industry is regulatory affairs specialist. These personnel analyze new and existing regulations in relation to an organization’s products or processes. They also review marketing, legal, and technical documentation, including case files and clinical research reports, to assess compliance with global regulatory agency policies, regulations, and standards. Regulatory affairs specialists may also recommend courses of remediation to help companies achieve the necessary levels of compliance. Acting as a liaison between manufacturing organizations and federal agencies, they may be responsible for submitting critical regulatory documents, with the goal of approval for sale and distribution.
Senior-level regulatory professionals often make strategic business decisions that have significant legal and financial repercussions. A large part of a regulatory affairs role, at all levels, is to interpret and communicate these implications to a diverse set of internal and external stakeholders.
Regulatory professionals are also often a voice in conversations at the cutting edge of health and public policy. Dr. Darin Detwiler, assistant dean and director of Northeastern’s Master of Science in the Regulatory Affairs of Food and Food Industries program, says that regulatory work is more than a job; it’s a mission.
He says his goal as a regulatory leader and educator, “is not just to send students forth with degrees, but to build effective leaders and change agents in the health and food industries. [Regulatory work] is a big part of the solution to major public health and food safety challenges.”
What’s the Job Outlook and Market Demand?
As the regulatory affairs discipline plays an integral role in global health, food safety, and medical innovation, it’s no surprise that the job market is growing. In 2016, the U.S. regulatory market experienced a 42 percent increase in job listings, and the U.S. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until 2026. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase.
Where Do Regulatory Affairs Professionals Work?
Along with the promise of job security, pursuing a career in regulatory affairs affords you a great deal of flexibility in where you choose to work.
As of 2016, 76 percent of regulatory professionals work directly in a regulated industry, such as pharmaceuticals, medical device, biotechnology, or food science. Approximately eight percent choose a consultative path, gaining employment at legal, research, or marketing firms. The remainder are employed by a mix of academic institutions, clinical research organizations, government agencies, hospitals, and healthcare organizations. With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees.
How Much Do Regulatory Professionals Earn?
Much like the setting and scope of a regulatory job, regulatory salaries vary, depending on job function, previous regulatory experience, seniority, geographic market, and highest earned degree.
And as market demand has increased, employers are willing to pay more for the right level of skill. Since 1995, salaries across all regulatory professions has maintained a general upward trend, increasing by an average 3.3 percent per year. Currently, the average yearly salary for regulatory professionals at all levels is $150,422.
According to the Regulatory Affairs Professional Society’s (RAPS) 2016 report, the national average total compensation for U.S.-based regulatory professionals by job level is:
- Vice President: $308,389
- Director: $203,119
- Manager: $134,019
- Project Manager: $112,174
- Specialist: $93,376
- Associate: $83,386
What Education and Training is Required?
“Breaking into the global regulatory affairs industry is in many ways unlike pursuing medicine or law, where the path to a successful career may be more established or clear-cut,” Amato says.
Unlike these areas, effective regulatory professionals come from a variety of backgrounds; there is no one degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business.
What’s encouraging to aspiring industry workers is more than 88 percent of current regulatory professionals began working in a different industry before transitioning into regulatory affairs, according to the 2016 RAPS report. Most of these individuals worked first in related industries, such as research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering.
A majority of regulatory workers earn undergraduate degrees in the disciplines of life science, clinical science, public health, or engineering, but others begin in unrelated areas, such as business, economics, or liberal arts. Regardless of your undergraduate focus, most prospective employers are more concerned with finding someone who possesses advanced regulatory knowledge and hands-on experience—two qualifications you can gain in a graduate program.
Earning an advanced degree in regulatory affairs will not only make you more marketable to employers, but it will also yield career opportunities that might have otherwise been inaccessible. According to data from Burning Glass Technologies, 42 percent of all regulatory employers require or strongly prefer candidates with a graduate degree.
Current Trends in Regulatory Affairs
According to Amato and Detwiler, there are several emerging trends influencing hiring patterns in the industry. These advances will likely expand the scope of work for regulatory professionals and shift employer demand toward new skills.
- Electronic Common Technical Document (eCTD): The FDA recently passed legislation requiring a new electronic format for regulatory submissions, spurring development of new software platforms and accompanying protocols. Individuals who acquire this eCTD competency will be in high demand.
- Blockchain: Food industry stakeholders around the globe are uncovering ways to use blockchain technology to improve the transparency, efficiency, safety, and authenticity of food supply chains. With a number of new organizations entering the blockchain supply chain arena, there will be an increase in hiring regulatory leaders to support their strategic vision.
- Social Media: Companies in regulated industries are beginning to focus on the use of social media to market products. As social platforms evolve, organizations seek to develop guidelines to regulate social communication and language to ensure consistency with product and labeling information. Individuals who stay abreast of these industry changes and keep their skill sets current will be well-positioned for future jobs.
So How Do I Get Started?
Amato says while regulatory job openings are abundant, companies are struggling to find the right level and combination of skills to fulfill their needs. Here are some suggestions for developing a competitive advantage to land the job:
The work of regulatory professionals is continuously shifting and expanding due to evolution in law, regulatory environments, technology, and global economics. Keep your regulatory knowledge base current by scanning multiple sources of regulatory affairs material daily to stay up-to-date on global changes in food and drug regulation.
Amato’s favorite sources include the U.S. Food and Drug Administration, Federal Register, and Drug Information Association. Subscribing to updates from publications such as Food Safety Magazine or Medical Device Manufacturers Association can also provide you with industry-specific updates to help you stay relevant.
Sharpen Your Skills
Regulatory projects are usually complex, time-constrained, cross-functional, and resource-intensive. Be proactive and focus on refining skills that complement this type of work, such as strong communication, critical and analytical thinking, negotiation techniques, project management methods, and a collaborative mindset.
Develop a Global Perspective
Currently, 74 percent of U.S.-based regulatory professionals have multiregional or worldwide responsibilities, and the number is likely to keep growing due to an increasing number of interconnected global regulations. Despite recent efforts to harmonize global regulations, many policies still diverge significantly. Regulatory professionals who can synthesize this information on a global scale to produce efficient, culturally agile programs will be highly valued.
Get Hands-On Experience
Detwiler says the real work of a regulatory specialist is not performed at a desk, but rather “in the manufacturing plant, the lab, the boardroom, or on the Senate floor.” In order to move beyond theory and into practice, you need to have real-world experience.
Gaining an advanced degree in regulatory affairs is one way to gain this experience and help you translate knowledge into action. At Northeastern, students in the regulatory affairs program have the opportunity to work alongside faculty on short-term, real-world projects at leading organizations. If you’re not ready to commit to graduate studies, seek out and take advantage of other experiential learning opportunities, such as internships or hands-on research.
Find Your Network
Locate mentors embedded in the industry to help advance your career. At Northeastern, graduate students have access to a global network of more than 3,000 employer partners and 230,000 active alumni, who work at leading biotech companies and global brands such as Pfizer, Biogen, Sanofi Genzyme, Boston Scientific, Merck, Kellogg’s, United Airlines, and Coca-Cola.
Organizations such as The Regulatory Affairs Professional Society and The Organization for Professionals in Regulatory Affairs offer global education, training, networking, research support, and other valuable career development resources. Get involved with these groups to strengthen your network and get ahead.
The world of regulatory affairs is far-reaching and constantly evolving, making it a dynamic choice for a career. As market demand continues to grow, it’s an opportune time for professionals of all levels to enter the field.