Regulatory Science & Regulatory Affairs: How They Keep Us Safe

Regulatory science applies scientific methods to examine public safety impacts of new technologies, products, and treatments. It guides agencies like the FDA, EPA, and OSHA in creating evidence-based regulations that protect public health without stifling innovation. Careers span federal agencies, pharmaceutical companies, and research institutions, typically requiring bachelor's to doctoral degrees in science fields.

Regulatory science sits at the intersection of research and policy, using scientific evidence to shape the rules that protect public health and safety. When the FDA evaluates a new medication, when OSHA sets workplace safety standards, or when the EPA determines acceptable pollution levels, regulatory scientists provide the research foundation for those decisions.

This field has grown dramatically since the 1970s, responding to everything from pharmaceutical tragedies to environmental disasters. Today's regulatory scientists tackle emerging challenges from data privacy to climate change, working across federal agencies, private industry, and research institutions. The field combines rigorous scientific analysis with policy expertise to ensure technological advancement serves the public interest.

If you're drawn to science but also interested in public policy, regulatory science offers a career path that combines both. It's become increasingly necessary as the pace of technological change accelerates and the stakes of getting regulations right-or wrong-grow higher. Here's what you need to know about the field, career pathways in environmental policy and planning, and how regulatory science degree programs prepare you for this work.

Jump to Section

• What is Regulatory Science?
• Career Pathways in Regulatory Science
• Education & Training Requirements
• Salary & Job Outlook
• How US Agencies Use Regulatory Science
• Regulatory Science: The International Picture
• Regulatory Science in the US: The Major Milestones
• Future Challenges for Regulatory Science and Compliance
• Frequently Asked Questions
• Key Takeaways

What is Regulatory Science?

Put simply, regulatory science examines the public effects of each technological advancement. It's the set of regulations, standards, rules, and legal frameworks governing environmental impact, public health effects, workplace safety, and the proper use of equipment and technology. In the US, this work involves licensing through agencies such as the FDA, safety checks by OSHA, and environmental impact assessments by the EPA.

The field uses scientific investigation both as qualitative research (examining opinions, perceptions, and social impact) and as hard science (using statistics and other quantitative methods to quantify impact levels). This dual approach allows regulatory scientists to assess not only what the data shows but also how new technologies affect real people and communities.

Regulatory science encompasses four core areas. First, regulatory affairs addresses governmental responsibility for protecting public safety and ensuring that collective health isn't endangered by scientific applications. The FDA's examination of medication side effects and pesticide impacts on the food supply exemplifies this work. Second, regulatory writing involves analyzing data and producing reports for stakeholders-government decision-makers, regulators, and industry leaders-to inform decisions with comprehensive information.

Third, risk management enables decision-makers to identify tangible, likely risks. Even when regulatory analysis highlights potentially severe consequences (such as a nuclear power plant meltdown), risk management defines probability thresholds and mitigation strategies. Finally, compliance, regulation, and law ensure that producers granted licenses to create potentially risky products or services maintain safety standards. Inspectors conduct regular checks to verify compliance with guidelines, with enforcement from both industry and government.

The concept of regulatory science programs ensures that humans, society, and the economy all benefit from technology and scientific applications without suffering harm.

Career Pathways in Regulatory Science

Regulatory science careers span diverse sectors, each offering distinct opportunities and work environments. Understanding these pathways helps you identify where your scientific interests and policy concerns might intersect with meaningful employment.

Federal Agency Careers

Federal agencies employ many regulatory scientists, and private industry employs significant numbers as well. These positions combine research responsibilities with policy development, often requiring you to translate complex scientific findings into actionable recommendations for policymakers. You'll work alongside interdisciplinary teams-toxicologists, epidemiologists, environmental scientists, engineers-to evaluate everything from new drug applications to industrial emissions standards.

The work environment is collaborative and mission-driven. You might spend mornings reviewing research submissions, afternoons consulting with industry representatives, and evenings drafting policy recommendations. Job security is generally strong, with competitive benefits and clear advancement pathways. Career progression often moves from technical review roles to team leadership, program management, and eventually policy-level positions.

Private Industry Positions

Pharmaceutical companies, medical device manufacturers, chemical producers, and technology firms all need regulatory affairs specialists. These professionals navigate the approval process, ensuring their company's products meet regulatory standards before reaching the market. You'll serve as the bridge between your company's research teams and government regulators.

Private-sector salaries typically exceed those in federal positions, though work can be more demanding with tighter deadlines. You'll need strong communication skills to advocate for your company's innovations while maintaining scientific integrity. Many professionals appreciate this sector's faster pace and direct connection between their work and tangible product launches.

Consulting and Research

Consulting firms hire regulatory scientists to advise multiple clients on compliance strategies, risk assessments, and regulatory pathways. This work offers variety-you might help a startup navigate FDA approval one month and assist an established company with EPA compliance the next. Research institutions and think tanks employ regulatory scientists to study policy effectiveness, propose regulatory frameworks for emerging technologies, and provide independent analysis.

These positions suit those who enjoy diverse projects and strategic thinking. You'll need adaptability and strong project management skills, as you're often juggling multiple clients or research streams simultaneously.

State and Local Government

State environmental agencies, public health departments, and local regulatory bodies implement and enforce federal standards while addressing region-specific concerns. These roles often have a more direct impact on the community-you might develop air quality standards for your state or investigate local environmental health concerns. The work tends to be more applied and immediately tangible than federal positions.

Education & Training Requirements

Educational pathways into regulatory science vary by target sector and specific role, but all emphasize strong scientific foundations and policy understanding.

Bachelor's Degree Foundation

Entry-level positions typically require a bachelor's degree in a relevant science field. Common majors include biology, chemistry, environmental science, toxicology, pharmacology, or engineering. During your undergraduate years, focus on building strong analytical and communication skills-you'll need both to succeed in regulatory roles.

Look for programs offering courses in environmental policy, public health, or risk assessment alongside your core science curriculum. Internships with federal agencies or industry regulatory affairs departments provide invaluable experience. The FDA, EPA, and other agencies offer student programs that can lead to full-time positions after graduation.

Master's Programs

Master's degrees significantly enhance career prospects and earning potential. Specialized programs in regulatory science or regulatory affairs combine advanced scientific training with courses in policy, law, and business. You'll study regulatory frameworks, risk assessment methodologies, clinical trial design, and regulatory writing.

Many programs offer concentrations in specific areas, such as pharmaceutical regulation, environmental policy, food safety, or medical devices. Some are designed for working professionals, offering evening or online formats. A master's degree often positions you for mid-level roles with greater responsibility and faster advancement potential.

Doctoral Degrees and Research Positions

PhDs are increasingly important for senior scientific roles, particularly in federal agencies and research institutions. Doctoral training provides the deep expertise needed to evaluate cutting-edge research and develop novel regulatory approaches. Fields such as toxicology, epidemiology, pharmacology, and environmental health often lead to careers in regulatory science.

If you're pursuing research-focused regulatory science, your dissertation should address real-world policy questions. Many successful regulatory scientists complete postdoctoral fellowships at agencies such as the FDA or the NIH, gaining direct experience with the regulatory process.

Professional Certifications

The Regulatory Affairs Certification (RAC) credential, offered by the Regulatory Affairs Professionals Society (RAPS), demonstrates expertise in regulatory affairs. While not required, this certification strengthens your credentials and shows commitment to the field. Certifications exist for domestic (US) and international regulatory affairs, with specializations in pharmaceuticals, medical devices, and other sectors.

Continuing education remains important throughout your career as regulations evolve and new technologies emerge. Professional organizations offer workshops, conferences, and online courses to help you stay current.

Salary & Job Outlook

Regulatory science encompasses several occupational categories, each with distinct salary ranges and growth projections. Understanding these differences helps you set realistic expectations and plan your career trajectory.

Salary by Sector and Experience

Note: Salary ranges based on BLS and industry reports. Actual earnings vary by location, experience, and sector.

Several factors influence compensation in regulatory science. Education level plays a significant role-PhDs typically earn more than those with master's or bachelor's degrees, particularly in research-focused positions. Geographic location matters considerably, with metropolitan areas and regions with high costs of living offering higher salaries. Your specialization also affects earnings, with pharmaceutical and medical device regulation often commanding premium compensation. Years of experience and demonstrated expertise in navigating complex regulatory processes also increase your earning potential.

Job Growth and Demand

According to the BLS, job growth for environmental scientists is projected at 6% from 2022 to 2032, with over 6,900 annual openings. Epidemiologists are projected to grow 27% over the same period. These projections reflect growing demand for regulatory science expertise across multiple sectors.

Several factors drive demand for regulatory scientists. First, the accelerating pace of technological innovation-from gene therapies to artificial intelligence-creates an ongoing need for regulatory frameworks. Second, growing public concern about environmental health, climate change, and product safety increases pressure on agencies to strengthen oversight. Third, globalization requires companies to navigate multiple regulatory jurisdictions, increasing demand for regulatory affairs expertise.

Emerging areas show particularly strong growth potential. Regulatory frameworks for AI and machine learning applications are still developing. Gene-editing technologies such as CRISPR require new approaches to safety assessment. Climate change drives demand for environmental regulatory expertise. Pandemic preparedness and rapid vaccine development processes need regulatory scientists who can balance safety with urgency.

How US Agencies Use Regulatory Science

Many aspects of our lives involving scientific applications carry potential risks. The materials we release during industrial processes, the vehicles we use daily, the food we eat, the air we breathe, and substances used in workplaces all present potential hazards. It's down to regulatory science agencies to determine which are inherently safe, which are safe with proper handling, and which require strict regulation or limited access. The US has numerous regulatory agencies covering most areas of daily life.

Public Health Protection: FDA and Medical Oversight

Formed in 1906 as one of the country's first regulatory science bodies, the Federal Drug Administration does far more than license medications. It's responsible for food safety and dietary supplements, alcohol and tobacco regulation, vaccines and biopharmaceuticals, veterinary products and animal foods (both pet and agricultural), and medical electronic equipment.

Every medicine or medical treatment comes with health risks. These include side effects (few medications come without at least a long list flagged during research), potential overdose consequences, and long-term health damage. The FDA weighs all evidence for new drugs to determine whether licensing for treatments is appropriate. Even after approval, it maintains regulatory and monitoring schemes for quality control. Their primary responsibility is protecting American citizens by applying rigorous science from before a drug reaches the market through its post-release period.

Faced with the growing need for regulatory science, the FDA developed a strategic plan in 2011 covering eight broad priority areas (a ninth was added the following year). These include modernizing toxicology to improve product safety, stimulating innovation in personalized medicine and clinical evaluation, supporting new approaches to manufacturing and product quality, and future-proofing the agency against emerging technologies and methods. The plan also emphasizes harnessing data through appropriate collection methods, developing new preventive approaches to food safety, creating medically based countermeasures to threats such as bioterrorism and epidemic diseases, and helping consumers make informed choices through behavioral science.

Workplace Safety: OSHA and MSHA

The Occupational Safety and Health Administration, known as OSHA, is a division of the Department of Labor. Signed into law by Congress in December 1970 during the Nixon presidency, the OSH Act's mission was to enforce workplace safety, with a focus on hazardous practices and worker health. The agency creates new standards to reduce workplace injuries and deaths and ensures employees aren't exposed to unnecessary dangers.

OSHA's work centers on three core areas. First, they build awareness of employers' duty of care toward employees-ensuring safe workplaces, explaining the nature of hazards and hazardous materials, providing training in clear terms, and maintaining records of risks and actual injuries. Second, they determine that protocols are satisfied, not just by following up after workplace safety incidents but also by ensuring proper and timely notification to the agency. Third, they protect workers' rights related to workplace safety, allowing employees to file complaints if they believe their safety is at risk and ensuring full disclosure of employers' safety records and medical information.

OSHA's creation has proven successful. Since its inception, it has saved many lives and prevented both major and minor injuries. Statistics suggest such incidents have declined by more than half without affecting productivity or business costs. OSHA regulations cover employees in private and public organizations (including local, state, and Federal government). Not covered are the self-employed, family members of agricultural employees, and workplaces covered by other Federal agencies.

Mining is widely recognized as one of the world's most dangerous occupations. The Mine Safety and Health Administration (MSHA) ensures that any mine operating within US borders, waters, or overseas territories adheres to safety regulations and law as determined by the Federal government. This includes the mine's engineering, drilling, and mining safety rules, and what to do during leaks or spills (though wider environmental damage usually falls under EPA responsibility).

MSHA enforces the Federal Mine Safety and Health Act (1977), which concerns public and employee health during mining operations and sets standards for accident reporting, actions, and consequences. They use regulatory science-an evidence-based approach to structure, ventilation, airflow, occupational safety, risk management, and incident response-to reduce deaths and injuries. In 1977, their foundation year, 242 miners died. By 2015, that fell to 28.

Environmental Protection: EPA and DOE

Although founded by President Nixon in 1970, the Environmental Protection Agency's eventual establishment was rooted in nearly a decade of environmental health activism that began during the Kennedy presidency. The Clean Air Act is considered a landmark in US environmental public health history. Its foundation emerged around the time climate change began to develop as a major scientific paradigm. Its core mission has been to regulate industry and daily life to protect human and environmental health. In recent decades, it has sought to impose regulations (set out in law) to limit carbon emissions from industry and motor vehicles, the two sources most responsible for climate change.

The EPA conducts environmental assessments to ensure compliance with laws and to keep our air, water, and land clean and safe for people and ecosystems at local, national, and global levels. It works with state governments, which, in some cases, are responsible for monitoring and enforcing compliance. Its remit includes routine research and investigation into environmental issues, regulating laws concerning pollution and carbon emissions while advising the Federal government, consulting with government bodies and engaging with industry for mutually agreeable outcomes, enforcement powers such as fines and jail times for violators, and maintaining public health, ecological balance, and biodiversity while conserving future landscapes and species from long-term anthropogenic damage risks.

The agency has made clear that its future development will include greater transparency to the public and stakeholders.

The Department of Energy oversees domestic and international energy policy. It manages nuclear energy production, the nation's nuclear arsenal, radioactive waste disposal, and domestic energy production. However, it also has responsibilities at the other end of the spectrum-promoting, researching, and developing renewable energy, advancing energy security, and addressing conservation issues. Externally, it oversees genomics research and sponsors many physical science programs.

Its place in regulatory science began in 1975 with the Energy Policy and Conservation Act, building on more than 15 years of pressure to establish conservation and environmental awareness at the heart of government. It establishes federal guidelines and standards for appliances and equipment, primarily related to safety. With the global need to reduce carbon emissions, the focus has shifted toward energy efficiency in everyday appliances such as refrigerators and washing machines, bulbs and batteries, and other energy-consuming devices. Today, many appliances must comply with energy conservation standards and safety protocols.

Rules are made through multistep consultation, including Congress with DOE advisement, and sometimes by seeking public input. They may also seek industry input and consider waivers when products are upgraded with new features, consulting manufacturers on regulatory implications.

Consumer and Product Safety: CPSC and Coast Guard

Are the goods we purchase for our homes safe? Do they represent a fire risk, a danger to our children, or are they toxic if swallowed or otherwise ingested? Are there environmental toxicology issues? The Consumer Product Safety Commission issues product recalls and refuses permission for sale if any product that any company wishes to sell in the US represents an unreasonable risk to health and safety. This was once the responsibility of state governments and industry, but it was considered inadequate.

The CPSC works extensively with third parties, including family groups, consumer organizations, and industry, to ensure that we, as consumers, make safe choices for ourselves and our families when purchasing goods. They take into account evidence from disciplines such as toxicology, chemistry, and biology to set rules on use, such as minimum ages for sale or outright bans. They use "citizen science," report data on safety issues, and compile information before issuing rulings, sharing their findings publicly and using them to regulate markets and sales. The CPSC is considered one of the most scientifically rigorous federal government organizations. When an industry voluntarily agrees to a standard, it tends to allow self-regulation. When the Federal government enacts a product-safety law, it enforces it (for example, by regulating cigarette sales).

Perhaps not an area that springs to mind when considering regulatory science in practice, but the US Coast Guard is responsible for many public safety issues as well as its military mission. It began in 1790 when the US began developing as a maritime power, and is now the oldest maritime arm of any US government agency or body. Its responsibilities include assessing the economic and environmental impacts of its decisions (as required under Federal law and enforced by the EPA) and complying with regulations expected of the USCG.

Data and Privacy Protection: HIPAA and OCR

The Office for Civil Rights, a division of the U.S. Department of Education, has limited regulatory authority over science. The most prominent is HIPAA-a law signed by President Bill Clinton in 1996. It mandates the protection of patient healthcare information at clinics and hospitals, their insurance providers, and any involved legal representatives. While some HIPAA provisions address human action and efforts to mitigate human error and carelessness, there are also regulatory implications for data science. Some provisions specify the nature and state of technology required to protect that data, including details on computer systems and storage methods, data portability, permissions, encryption, and access controls.

Regulatory Science: The International Picture

Regulatory science and compliance were, until relatively recently, considered to operate in isolation within each country. What the US does in terms of regulating and licensing products and medication has little bearing in Japan, the European Union, the Middle East, or even our major markets in South America, except for international companies operating within those jurisdictions. However, globalization has brought disparities and conflicts into stark relief, and there is a need for change and cooperation. A globalized world requires, at least for simplicity, something resembling a degree of alignment on standards so that organizations seeking to operate in multiple jurisdictions can do so.

This isn't always the case in practice. While one country perceives something as safe or harmless, another may perceive the same practice or substance as unsafe or even harmful. One present issue is GM labeling-mandated in the US, voluntary in the EU. This could cause confusion for consumers, the industry, and international regulators.

There are areas where regulatory science adoption is already useful, or could be, especially in emerging sciences. Regenerative medicine is one of those areas, a move that's especially welcome as the US, Japan, and European Union member states are at loggerheads over what constitutes effective legislation and industry standards on regulation. The main reason for the differences concerns the healthcare available to citizens. Regulatory science could prove key in bringing together a unified idea on how to approach this and other sciences. Even in medical science, regulatory science is never simple. If one medicine is licensed for use in one country, it doesn't necessarily follow that others will license it too. This has been problematic since the 1990s, when regulatory science began to internationalize.

One great regulatory science success story comes through United Nations bodies. Organizations such as the IMO (International Maritime Organization) set legal criteria for shipping, covering environmental issues, workplace safety, and safe practices. Similarly, the International Civil Aviation Organization performs similar functions for aviation. Thirdly, the legal international framework centering on nuclear weapons and the use of chemical and biological weapons through the Organization for the Prohibition of Chemical Weapons.

Regulatory Science in the US: The Major Milestones

Regulatory science is a relatively new area, blending applied and research science with government policy and public health responsibilities. Many argue it began in the 1970s, when numerous regulatory bodies formed to address public concern and growing evidence that practices could harm people and ecosystems.

1800s: Arguably the first threads of regulatory science in the pharmaceutical industry. It was the end of the Enlightenment, and public health was evolving. Modern pharmaceuticals, as we know them, began here. It required drug regulation with standards set down on treatments and doses, even though these may have been fairly rudimentary and much looser by today's standards. This became tighter through the century until the 1848 Import Drugs Act, which required standards of purity and strength.

1906: This was the year of the Federal Food and Drugs Act, which would eventually lead to the FDA's creation, the body now responsible for medication and food licensing. That would come in 1930, but the FDA claims that, thanks to new powers and the reorganization of existing authorities, it was born in 1906.

1950s: By the modern age, old standards were proving inadequate. This decade saw several vaccine and medication tragedies, with Thalidomide being the most prominent. The developed world was once again forced to consider regulating medical treatments to prevent events such as the Vaccine Tragedy and Thalidomide from happening again.

1962: Rachel Carson's book, Silent Spring, forced the US and the world to consider the potential harm of lacking scientific regulation in industrial agriculture and to think about the potential harm we could do to our planet. Despite coming under attack from several industries, she won support from the Kennedy administration. Regulation would take several years and carry on beyond Kennedy's assassination.

1964: The Helsinki Declaration set down a series of ethical standards regarding human experimentation for medication. Developed by the World Medical Association, it's now considered the most important global regulatory framework for research ethics. However, it's not legally binding on any nation but is an important cornerstone for medical licensing and other regulations for individual countries' legal frameworks.

1969-70: Foundation of the Environmental Protection Agency in 1970, followed by several years of consultation. The previous year, the National Environmental Policy Act required all Federal agencies to prepare an environmental impact assessment for any actions that could affect the environment. However, it must be noted that the framework for assessing environmental impact didn't yet exist. 1970 marked the birth of environmental science; the tools and methods were young, as were the concepts of ecology and the importance of equilibrium in ecosystems.

1971: OSHA's foundation, the Occupational Safety and Health Administration, under the Department of Labor's jurisdiction, was established after being signed into law by President Nixon in 1970. Finally, American workers would receive safety protection and a duty of care from their employers. Its immediate aim was to reduce workplace deaths and injuries without affecting productivity or profitability. Employers are subject to ongoing review and law changes. In recent years, OSHA has issued updated standards for electrical protective equipment, emergency routes, fire action plans, and more. OSHA uses the scientific method to establish safe working levels for chemical substances, identify materials for PPE, and apply medical standards for tasks such as safe lifting.

1972: Alvin Weinberg writes a seminal paper on "trans-science." Although credited with effectively establishing regulatory science, this claim has many detractors. He never uses the term "regulatory science" and was speaking in general terms about things science could prove, but questions that were unanswerable. What he effectively did was create a solid framework for using science in public decision-making.

1987: This is the year the term regulatory science is first used. In a paper that year, Sheila Jasanoff discusses "policy-relevant science." She's now considered one of the founders of the regulatory science movement and coined the term in 1990 in her follow-up book. In reality, however, it had been nearly two decades since governments began expecting science to determine some matters of public policy.

1996: HIPAA's introduction that year finally brought regulatory science out of the realms of personal safety and into the world of growing concern about data. This was the birth of the internet, and already, people and government were concerned about who could collect what sensitive data. In addition to determining what can be held, who can hold it, and who can access it, HIPAA uses information science to establish criteria for data protection and encryption.

2011: It was inevitable that regulatory science would become a matter of global interest. Globalization was, by 2011, at least a decade old. That meant organizations seeking to trade internationally would need to ensure compliance with requirements in every jurisdiction. The Global Summit on Regulatory Science began in 2011 to help address regulatory issues. They discuss medical science issues, food safety, and public health, but also developing technologies for which there may not yet be a framework, such as nanotechnology.

2015: Unlike the Kyoto Protocol, the Paris Agreement of this year attempted to set down, using our understanding of modern environmental science findings, a binding set of procedures to address global greenhouse emissions. Although it didn't determine what each would be for each country (it allows individual autonomy), it agreed to set a maximum temperature rise of 2�C for the remainder of the century. To many, this is unenforceable, especially when requirements are so loose. However, it's the most robust agreement to date that uses science to establish standards for a voluntary arrangement. Future decisions may be legally binding.

Future Challenges for Regulatory Science and Compliance

As you can see from regulatory science's short history, most issues that have arisen (and even before there was such a field) have been addressed reactively rather than proactively. Most regulations are enacted by governments in response to problems that arise rather than those foreseen. That situation's unlikely to change as industries grow ever more complex and new technologies arise with unforeseen problems. Here are the present and future challenges for regulatory science.

Data Science, Big Data, and GDPR

The internet has been around (as a public medium) for around 25 years. During that time, access speeds and the types of media we use have changed rapidly. We can now store and transfer more data than ever before. In this age of Big Data as a marketing and research tool, governments and individuals are starting to ask questions about the volume of data that third-party organizations hold about each of us, its inherent value, and whether we even want them to use and handle it. In May 2018, the European Union instigated the GDPR-General Data Protection Regulation. It applies to EU member states. Any organization that handles data on any EU citizen is now required to comply with the regulation, which could have significant implications for how businesses and public organizations in the US handle such data.

There's no plan at present for the US to introduce anything like GDPR, but this and future administrations will almost certainly watch developments in the European Union for the time being to determine whether GDPR is robust in protecting consumer rights while simplifying standards for organizations, whether or not it hinders or helps data commerce, the potential future implications for such a regulatory science framework here in the US and for global data trade, and the implications for such a regulation on science research, particularly for biomedicine and medical science research.

"Harmonization and Convergence": Managing Competing Ideas

We live in a global world, and for researchers and private organizations, that often means managing competing approaches to regulatory science worldwide. A medicine or treatment that may be legal in the US may not have been licensed in the EU, and vice versa. Chemicals or other raw materials used in biomedical research, for example, may be perfectly legal in one jurisdiction and not in another. Yet global cooperation can benefit large-scale and international research programs. In this case, the challenge for regulatory science is to ensure that new technological developments can proceed with as few restrictions or regulations as possible, and to work together on both national and international frameworks to preserve jobs while adhering to local customs and laws. Given the global market, the ease of such cooperation with lower trade barriers, and the realization of mutual benefit, many research sectors are taking steps toward regulatory convergence.

There's a current major disagreement between the US and EU regarding restrictions on GM. The latter has some of the world's strictest regulations regarding GM in food and feed. The US believes the regulations are unscientific and designed more to appease a concerned public than to protect trade. Another potential conflict is whether any organization may patent a modified gene as intellectual property.

Public Safety vs Economics

Public safety has always been paramount for regulatory science. The EPA, OSHA, and FDA were all formed with protecting citizens and ensuring public safety in mind. While industries continue to push the boundaries of technology and pharmaceutical development, it remains the responsibility of regulators and governments to ensure this occurs within the law. As new issues arise, new problems and challenges will continue to require vigilance and adaptation. So long as regulators continue to understand their vital role in protecting public health and ensuring safety, there shouldn't be a problem. But some concerns have been raised that economics and business interests have been allowed authority over public health.

Certainly, this is the accusation leveled at many governments for failing to act on threats to public health from climate change. Drought, flooding, increasingly erratic weather patterns, the unpredictability of previously generally predictable weather phenomena, and extreme weather as the new normal, plus the spread of tropical diseases outside their conventional habitats, certainly qualify as public safety issues. As the century goes on, the western world is expecting the number of refugees to increase from areas most at risk from food insecurity and political instability, where causes are related to the changing climate-these are "climate refugees." The IPCC has always sought to drive regulation based on scientific evidence as an anticipatory step, rather than the conventional reactive system. Encouraging governments to shift from a reactive to a proactive approach to regulatory science could be one of the 21st century's biggest challenges.

The Double-Edged Sword of Public Opinion

Public reporting has been a boon to research and public health. Often, reports of illness and side effects come through self-reported symptoms as a form of "citizen science," and inclusiveness will remain an important method for both outreach and data collection. However, what can be a great asset to research can also be a distraction at best or an anti-science movement at worst. A misinformed public, not mindful of potential problems such as confirmation bias, confusion between correlation and causation, and a willingness to believe conspiracy theories, can lead to media scare stories. This is certainly the case for issues such as the belief that vaccines cause autism and that GM is dangerous to public health. In the first case, multiple repeated studies have shown no link between vaccines and autism. In the second, public pressure has led food producers in the US to label their products "NON-GMO" to claim they're "safer" than GM crops, despite thousands of articles showing they are no more or less dangerous than conventionally grown crops. The same fear has led the EU to ban GM food for human consumption.

Issues such as public pressure can be problematic for regulators and the governments that fund and support such bodies, as they can divert attention from the science and lead them to bow to public pressure on safety matters. Regulatory science risks reacting to the wrong problems and legitimizing or enabling public concerns based purely on misunderstanding. This can be both resource and cost-intensive.

Misleading Food Labels

Public misinformation and a lack of scientific understanding can also hinder science's public outreach in any area. It's important that food producers, especially, don't mislead the public. While they can't make claims that are untrue (and will be penalized by the FDA for doing so), there's a further problem when food labels mislead the public by implication. Here, they're not technically lying but creating a perception through suggestion. For example, using terms such as "natural" implies that a product is healthier and safer than competitors. The reality is that the word "natural" has no legal definition. Negotiating the minefield of misleading claims, such as gluten-free organic water, can prove problematic in that, although the producer isn't lying about their product (which is against the law), it's that, by implication, their product has these values while others don't. Marketing gimmicks are increasingly misleading, and while various regulatory science bodies have historically been concerned with protecting public health, their remit in many cases also extends to the public interest. Arguing against nonsensical claims and marketing tactics designed to create confusion and a "knowledge gap" for consumers will likely be a major challenge going forward.

Frequently Asked Questions

What's the difference between regulatory science and regulatory affairs?

Regulatory science is the broader field that applies scientific research to inform policy decisions, while regulatory affairs refers specifically to the business function of ensuring that companies comply with regulations. Think of regulatory science as the research foundation and regulatory affairs as the implementation practice. Regulatory scientists conduct research and develop evidence-based recommendations, while regulatory affairs professionals navigate approval processes and maintain compliance for specific products or companies.

What degree do I need to work in regulatory science?

Entry-level positions typically require a bachelor's degree in a relevant science field such as biology, chemistry, environmental science, toxicology, pharmacology, or engineering. Advanced roles at agencies such as the FDA or EPA often require master's degrees or PhDs. Specialized master's programs in regulatory science or affairs combine scientific training with policy expertise. Your specific degree choice should align with your target sector-pharmaceutical regulation might favor pharmacology or toxicology, while environmental regulation often requires environmental science or chemistry backgrounds.

Do all regulatory scientists work for the government?

No. While federal agencies employ many regulatory scientists, significant opportunities also exist in pharmaceutical companies, medical device manufacturers, consulting firms, research institutions, and private industry. Companies need regulatory experts to navigate approval processes and maintain compliance. In fact, private-sector positions often offer higher salaries than government roles, though they may involve different work-life balance considerations.

What's the salary range for regulatory science careers?

Median salaries range from $60,000 to over $130,000, depending on sector and experience. Private industry typically offers higher compensation. Entry-level positions in state and local government might start around $50,000-$65,000, while senior-level roles in pharmaceutical companies can exceed $200,000. Federal government positions typically fall between, with mid-career professionals earning $85,000- $110,000 and senior scientists earning $120,000- $160,000. Geographic location, education level, and specialization all significantly impact earning potential.

Is regulatory science a growing field?

Yes. According to the BLS, job growth for environmental scientists is projected at 6% from 2022 to 2032, with over 6,900 annual openings. Epidemiologists are projected to grow 27% over the same period. Growth is driven by technological innovation, which requires new regulatory frameworks; rising public concern about environmental health and product safety; and globalization, which requires companies to navigate multiple regulatory jurisdictions. Emerging areas such as AI regulation, gene-editing oversight, and climate change policy show particularly strong demand.

Can I enter regulatory science from another science background?

Yes. Many successful regulatory scientists transition from other science careers. Your existing scientific expertise provides the foundation-you'd need to supplement it with regulatory knowledge through continuing education, professional development courses, or a master's degree in regulatory affairs. Many employers value diverse scientific backgrounds because they bring fresh perspectives to regulatory challenges. Consider pursuing the RAC (Regulatory Affairs Certification) credential to demonstrate your commitment to the field.

What skills are most important for regulatory scientists?

Beyond strong scientific knowledge, you'll need excellent analytical skills to evaluate complex research data, clear communication abilities to translate technical findings for policymakers and the public, attention to detail for reviewing lengthy documents and identifying potential safety concerns, problem-solving skills to address novel regulatory challenges, and ethical judgment to balance innovation with public safety. Understanding both the scientific method and the policy-making process is essential.

Salary and career outlook information sourced from the US Bureau of Labor Statistics. Data reflects national averages and may vary by location, employer, education level, and experience. Information accessed January 2026.

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Matthew Mason

MG Mason has a BA in Archaeology and MA in Landscape Archaeology, both from the University of Exeter. A personal interest in environmental science grew alongside his formal studies and eventually formed part of his post-graduate degree where he studied both natural and human changes to the environment of southwest England; his particular interests are in aerial photography. He has experience in GIS (digital mapping) but currently works as a freelance writer as the economic downturn means he has struggled to get relevant work. He presently lives in southwest England.

Latest posts by Matthew Mason (see all)

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How Geographic Information Systems (GIS) Transform Sustainability Work

Geographic Information Systems (GIS) transform sustainability work by integrating environmental, economic, and social data into visual, actionable formats. GIS enables conservation planning, resource management, climate monitoring, and cross-border collaboration on critical environmental challenges. From documented projects like Puerto Rico's Conservation...