Regulatory affairs professionals help companies in industries with highly complex regulations safely and effectively bring products to market. In the biopharmaceutical industry, the regulatory affairs role takes on added importance due to the varying types of regulations that impact the treatments and the scientific processes used to produce those treatments.
“It’s very different than a lot of fields,” says Steven A. Kates, an assistant professor in the College of Professional Studies at Northeastern University and a 30-year veteran of the pharmaceutical industry. “To bring a drug to market in biopharma, regulatory affairs professionals need to engage with a number of departments, including synthetic chemistry, toxicology, pharmacology, biostatistics, clinical, and marketing. You are the center. There is no other field that interacts with this level of sophistication.”
Keep reading to learn how biopharmaceutical regulatory affairs differs from regulations in other industries and explore tips for professionals looking to advance their careers in this field.
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The Role of Regulatory Affairs in the Biopharmaceutical Industry
In biopharmaceutical companies, regulatory affairs ensures that treatments are developed in accordance with the regulatory guidelines of the country in which the company does business.
In the United States, the Food and Drug Administration sets the regulations for clinical trials, drug authorization, and drug approval. In the European Union, the European Medicines Agency (EMA) has this responsibility. In Japan, this authority rests with the Pharmaceuticals and Medical Devices Agency.
Broadly speaking, the FDA approval process consists of four steps.
- Pre-clinical: The product is first developed and then tested on animals.
- Clinical: The product enters three phases of trials with human subjects; an FDA review occurs after the second phase.
- Review: The company applies for approval; meanwhile, the FDA inspects the facility where the drug is made.
- Post-Marketing: The drug is approved; while on the market, the manufacturer must submit safety updates.
There are a number of exceptions to this process designed to make treatments available to the general public faster. Companies can request specific review processes known as Fast Track, Breakthrough Therapy, and Priority Review if they believe a treatment meets a specific market need. In other cases, such as the vaccines for COVID-19, the FDA may decide to expedite the process by granting emergency use authorization when no other alternatives are available.
Why the Regulatory Affairs Role is Valuable for Biopharma Firms
Large biopharmaceutical firms typically have a business leader responsible for all regulatory affairs matters and individuals who focus on specific countries or regions of the world, Kates says. The person in this regulatory leadership role typically reports to the company’s chief medical officer.
According to New Scientist, the regulatory affairs professional’s primary role is to serve as the link among a company, the regulatory agencies, and the product being developed. Key responsibilities include collecting and interpreting data, ensuring regulatory compliance, preparing submissions that require regulatory approval, and advising executive leadership throughout the drug development cycle.
The primary value of these professionals in biopharmaceutical companies is their ability to make sense of government agencies’ guidance throughout the drug development process, Kates adds.
“The FDA or EMA will provide guidance. Anyone can read the guidance, but the most important thing is how you interpret it through your experience,” Kates says. “You want to balance what is the appropriate amount of work for that particular stage of drug development. Each phase gets more complex and more costly, and the FDA wants to see a treatment developed appropriately. You don’t want to spend hundreds of millions of dollars on the first phase, only to see a trial flop.”
The United States, European Union, and Japan are the typical starting point for drugmakers, as they are the three largest markets in the developed world, notes an article in BioPharm International. What’s more, the guidance offered by the agencies in those three regions during the review process will often apply to the requirements of agencies in other countries.
In contrast with larger biopharma firms, smaller companies may hire external consultants to fill the role of a regulatory affairs professional. A consultant may have extensive experience with the FDA review process, which would allow them to address specific questions from a firm that’s new to the drug development process. A consultant also brings global market expertise, which can be valuable to a firm of any size looking to expand beyond the United States, the European Union, or Japan.
How Pharmaceutical Regulatory Affairs Differ From Other Industries
Regulatory affairs for biopharmaceutical firms tends to be more complex than it is for firms in other industries, Kates says. Much of this comes down to the broad range of activities that are subject to regulation.
Just as different phases of the clinical trial process are governed by different FDA regulations, various activities throughout this process are subject to their own regulations. These regulated tasks include strategic planning, technical writing, day-to-day operations, and drug manufacturing, Kates notes.
In addition, regulations differ depending on the condition(s) that a treatment intends to address, Kates adds. Cancer treatments, for example, are subject to different regulations than treatments for heart disease, which are different from treatments for diabetes, and so on. As a result, large biopharma firms may employ regulatory affairs professionals with expertise in different disciplines depending on the types of treatments in development. In contrast, smaller firms may elect to bring in external consultants to fill these roles.
Another challenge stems from the closed-off nature of drug development. While regulations require companies to post that a clinical trial has begun, little else is made public until after a treatment receives approval, Kates says. That makes it difficult for students and professionals alike to research the work that other firms have done.
The private nature of the process, combined with its complexity and importance to the company’s bottom line, also means that young professionals have to learn on the job and gain experience before they can take on additional responsibility, Kates says. Firms don’t get many opportunities to appear before the FDA—and when they do, they have to be prepared.
“When you appear before the FDA, you get an hour. You have to make the most of that hour, because they are the judge and the jury, and you need their guidance and their agreement to move forward,” he says. “This position is critical for a major company, and you don’t see a lot of people doing that. You have to work your way up. Early on, your role is to sit and listen. It takes practice to get to Carnegie Hall.”
How to Build a Career in Biopharmaceutical Regulatory Affairs
Because a biopharmaceutical regulatory specialist’s role comes with several unique challenges, individuals who can do the job tend to be well compensated. According to Indeed, the average annual salary for a regulatory affairs manager is more than $110,000. Firms in the pharmaceutical and life sciences industries typically exceed that average, as do consulting firms.
Obtaining a master of science in regulatory affairs is a valuable step for anyone seeking a career in the field. That’s because regulatory affairs isn’t typically covered in undergraduate programs that are common starting points for a career in biopharma, such as biology or chemistry, Kayes points out.
“Just being able to cover the basic concepts enables you to overcome a big hurdle. I always tell students, ‘We’re going to try to expand your knowledge because there’s just so much to cover,’” he says. “My approach is to be as broad as possible—to have students work on different drugs for different indications, and then to share the results so that everyone is exposed to the different nuances of regulatory affairs.”
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