By Marcus Editorial Team | December 12, 2025

The Regulatory Affairs Career AI Can't Replace

At 38, Ihsan Mahmood had reached a breaking point. For seven years, he had worked as a hospital pharmacist in Manchester, dispensing medications during rotating shifts that left him exhausted and isolated from his young family. Weekend work was mandatory. Holidays were scarce. The physical and emotional toll of hospital pharmacy, compounded by post-pandemic staffing shortages, had pushed him to consider leaving healthcare entirely.

Then a former colleague mentioned regulatory affairs. "She told me pharmaceutical companies were desperate for people who understood drug formulations and could write well," Mahmood recalls. "I had never heard of the role, but when I looked into it, I realized it was exactly what I needed. Remote work. Normal hours. Better pay. And I could still contribute to patient care without the burnout."

Eighteen months later, Mahmood earns £72,000 annually as a regulatory affairs specialist for a mid-sized biotech firm, working entirely from his home office. He reviews clinical trial protocols, prepares regulatory submissions to the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and ensures his company's drug applications meet European Medicines Agency standards. His schedule is predictable. His stress levels have plummeted. And he has discovered a career path that artificial intelligence is transforming rather than eliminating.

While headlines trumpet AI's potential to automate everything from radiology to legal research, regulatory affairs represents a paradox: a field where artificial intelligence is creating more opportunities rather than fewer. The reason is both simple and profound. AI can draft documents and analyze data, but it cannot make the judgment calls that define regulatory work. And as pharmaceutical companies race to integrate AI into their operations, they need more humans, not fewer, to ensure compliance with rapidly evolving guidelines.

What Is Regulatory Affairs in Pharmaceuticals?

Regulatory affairs is the discipline that ensures pharmaceutical products, medical devices, and biological therapies comply with government regulations before, during, and after they reach the market. Regulatory affairs professionals serve as the critical interface between pharmaceutical companies and regulatory authorities like the FDA in the United States, the MHRA in the United Kingdom, and the EMA for European markets.

Regulatory submissions:

Professionals prepare and submit applications for new drug approvals, known as New Drug Applications (NDAs) in the United States and Marketing Authorization Applications (MAAs) in Europe, compiling thousands of pages of clinical data, manufacturing specs, and safety information.

Regulatory intelligence:

Teams monitor guidance updates across jurisdictions, interpret complex instructions, and advise R&D and commercial leaders on compliance strategies while responding to regulator questions that determine approval timelines.

Chemistry, Manufacturing, and Controls (CMC):

CMC is the section of the dossier describing how a drug is made, tested for quality, and maintained through its shelf life. Specialists with CMC expertise bridge chemistry, engineering, and compliance.

These responsibilities demand people who can translate science into regulator-ready documentation and influence cross-functional teams when new requirements surface.

The AI Transformation Creating Jobs, Not Destroying Them

The pharmaceutical industry stands at an inflection point with artificial intelligence. In January 2025, the FDA published draft guidance titled "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision Making", signaling that AI tools will become integral to drug development and approval processes. The European Medicines Agency followed with frameworks emphasizing risk-based approaches to AI deployment throughout the medicinal product lifecycle, crystallized in its 2023 Reflection Paper on Artificial Intelligence and Machine Learning.

According to research published by IQVIA in 2025, pharmaceutical companies are implementing AI across pharmacovigilance, medical information, and lifecycle management workflows to accommodate growing workloads. AI now handles automated adverse event data collection, processes high inquiry volumes in medical information departments, and assists with regulatory intelligence monitoring. A 2025 review in the American Journal of Biomedical Sciences and Research found that the market for AI in drug discovery alone is valued at $1.94 billion and expected to reach $16.49 billion by 2034.

But every AI system pharmaceutical companies deploy requires regulatory oversight. Someone must validate AI models according to Good Manufacturing Practice standards, ensure AI-generated content in regulatory submissions meets credibility standards, and document compliance for inspections. That someone is a regulatory affairs professional with new competencies in AI governance.

A study published in FDLI's Food and Drug Law Journal in August 2025 emphasizes that sponsors must explain how AI systems avoid discriminatory impacts, maintain clinical relevance, and undergo ongoing post-approval monitoring. These requirements create demand for professionals who understand both traditional regulatory frameworks and emerging AI validation protocols. Companies are establishing dedicated AI Quality functions that work alongside traditional quality assurance, opening entirely new career pathways.

IntuitionLabs, an AI software development company specializing in life sciences, reports that pharmaceutical companies implementing AI face a talent shortage. They need regulatory professionals who can draft Predetermined Change Control Plans for adaptive AI devices, assess model risk classifications, and communicate with regulatory agencies about machine learning applications. These are not entry-level positions. But they are accessible to career switchers and early-career professionals willing to acquire both regulatory and AI fundamentals.

The Salary Proposition: Competitive Pay with Geographic Flexibility

Regulatory affairs positions offer compensation that rivals clinical roles while providing significantly better work-life balance and remote work options.

In the United States, regulatory affairs specialists earn between $75,000 and $111,000 annually according to comprehensive 2025 data from PayScale and Glassdoor, with median salaries around $95,000. Entry-level associates start at $63,000 to $78,000, while senior specialists with five or more years of experience command $101,000 to $143,000. Regulatory affairs managers earn $116,000 to $188,000, with top pharmaceutical companies like Genentech, Takeda, and Gilead Sciences paying well above national averages.

In the United Kingdom, regulatory affairs specialists earn £35,000 to £49,000 annually, with mid-career professionals at £43,000 to £54,000. Regulatory affairs managers earn £42,000 to £66,000, with London-based roles offering premiums of 20 to 25 percent. Senior regulatory consultants in London can earn £82,000 to £102,000 according to 2025 Salary Expert data.

The field's growth trajectory remains strong despite broader economic uncertainties. O*NET data estimates 94,400 new regulatory affairs jobs will be available in the United States between 2022 and 2032. The U.S. Bureau of Labor Statistics projects 7 percent growth, faster than average for all occupations. A market analysis published in October 2025 notes that while the industry faces a shortage of experienced regulatory professionals, this creates opportunities for newcomers willing to acquire foundational skills.

Remote Work: The Regulatory Affairs Advantage

The COVID-19 pandemic forced pharmaceutical companies to discover what regulatory professionals had long suspected: much of their work requires deep focus, not physical presence. Regulatory submissions, document review, and agency communications can occur from anywhere with secure internet access.

According to job market data from Indeed and ZipRecruiter, hundreds of regulatory affairs positions advertised as remote or hybrid were available in the United States as of November 2025. Major pharmaceutical companies including Pfizer, Takeda, Nestlé Health Science, and W.L. Gore & Associates now routinely offer remote regulatory affairs positions, and professional bodies such as the Regulatory Affairs Professionals Society (RAPS) report that flexible arrangements have become a fixture in the 2024 compensation and benefits landscape.

Remote regulatory affairs specialists earn $31 to $93 per hour according to ZipRecruiter data, with many positions offering full-time remote arrangements with occasional travel for critical meetings or regulatory inspections. The qualifications remain consistent: a bachelor's degree in life sciences, pharmacy, chemistry, or related fields, plus two to five years of pharmaceutical industry experience.

For Ihsan Mahmood, remote work transformed not just his career but his entire life. "I have breakfast with my children now. I walk them to school. When they come home, I'm already here," he explains. "In hospital pharmacy, I was working while they were sleeping and sleeping while they were awake. This isn't just a better job. It's a completely different quality of life."

The regulatory affairs discipline lends itself to remote work because it centers on document preparation, data review, and strategic communication rather than physical laboratory work or patient care. Regulatory Information Management Systems like Veeva RIM allow teams to collaborate virtually on submissions. Electronic document management systems enable secure access to technical files from any location. Video conferencing facilitates interactions with regulatory agencies and cross-functional teams.

Who Can Transition into Regulatory Affairs?

The regulatory affairs profession draws talent from diverse backgrounds, offering multiple entry pathways for career switchers and early-career professionals.

Healthcare Professionals Seeking Better Work-Life Balance

Pharmacists like Ihsan Mahmood possess ideal qualifications. They understand drug mechanisms, read scientific literature fluently, and communicate complex information clearly. Hospital and clinical pharmacists often seek regulatory roles to escape shift work while maintaining connection to pharmaceutical science. Nurses with clinical trial experience transition smoothly, bringing patient safety perspectives that regulatory work prizes. The Regulatory Affairs Professionals Society reports that a large percentage of current regulatory professionals began in different healthcare roles before transitioning.

Recent Science Graduates Seeking Career Direction

Biology, chemistry, biochemistry, and pharmaceutical sciences graduates often discover regulatory affairs after struggling to find laboratory positions or realizing bench research does not suit them. Entry-level regulatory affairs associate positions start at £25,000 to £31,000 in the UK and $63,000 to $68,000 in the US, providing stable career foundations. Universities including Northeastern University, San Diego State University Global Campus, and the University of Georgia Online now offer specialized regulatory affairs master's programs and certificates designed for recent graduates.

Project Managers and Compliance Professionals from Adjacent Industries

Regulatory affairs rewards organizational skills, attention to detail, and process management. Professionals from quality assurance, compliance, project management, and technical writing backgrounds transition successfully by acquiring pharmaceutical-specific knowledge through short certificate programs offered by institutions such as Northeastern and SDSU Global Campus. TryMarcus.com complements those tracks with two micro-credentials particularly valuable for aspiring regulatory affairs professionals: Introduction to Clinical Trials and Introduction to Generative AI in Healthcare.

The Critical Skills AI Cannot Replace

While artificial intelligence excels at pattern recognition and data processing, regulatory affairs requires judgment that current AI systems cannot replicate. When a serious adverse event occurs, a human regulatory professional must determine whether it represents a new safety concern, assess its relationship to the investigational drug, decide on reporting timelines, and draft clear explanations for medical reviewers. These decisions involve interpreting ambiguous clinical data, weighing competing evidence, and communicating uncertainty.

Similarly, AI can draft sections of regulatory submissions by analyzing previously approved applications. But regulatory affairs specialists must ensure those AI-generated drafts accurately reflect their specific product, anticipate likely regulatory questions, and position the application strategically. Outcomes are measured not just in efficiency but in better compliance—fewer errors, faster detection of issues, and stronger readiness for inspections.

Regulatory strategy represents another domain where human expertise remains irreplaceable. When developing a global regulatory plan for a new therapy, professionals must navigate different approval pathways across jurisdictions, sequence submissions to optimize timelines, and adapt strategies based on agency feedback. These decisions require understanding regulatory agency cultures, predicting reviewer concerns, and managing stakeholder expectations.

The Training Pathway: Faster Than Medical School, More Structured Than Self-Study

Unlike medicine or law, regulatory affairs lacks a single prescribed educational trajectory. The most straightforward path involves completing a bachelor's degree in life sciences, gaining two to three years of pharmaceutical industry experience in roles like clinical trial coordinator or quality assurance associate, then pursuing Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society.

For those seeking faster entry, specialized master's programs in regulatory affairs compress learning into 12 to 18 months of intensive coursework. Career switchers benefit from micro-credential approaches. Completing Introduction to Clinical Trials and Introduction to Generative AI in Healthcare through platforms like TryMarcus.com provides foundational knowledge in eight to 12 weeks of part-time study. This demonstrates commitment to prospective employers while building genuine competency. Pair that with Marcus’s regulatory affairs learning path or outreach via the Marcus demo team for organizational rollouts.

Industry certifications accelerate career progression. Beyond the RAC, specialized certifications in areas like CMC regulatory affairs, pharmacovigilance, and medical device regulations command salary premiums. According to PayScale data, certified regulatory professionals earn 10 to 20 percent more than non-certified peers at equivalent experience levels.

Navigating the Job Market: Where Opportunities Concentrate

Regulatory affairs positions exist across the pharmaceutical ecosystem but concentrate in specific sectors and geographies. Pharmaceutical manufacturers employ the largest numbers, with companies like Pfizer, Merck, AbbVie, and GSK maintaining substantial regulatory teams. Biotechnology firms hire aggressively and value professionals who can wear multiple hats, making them excellent training grounds for early-career specialists.

Contract research organizations and regulatory consulting firms represent the fastest-growing sector, providing services to multiple clients and creating exposure to diverse therapeutic areas. Geographically, roles concentrate in Boston/Cambridge, the San Francisco Bay Area, New Jersey, Research Triangle Park, and greater Philadelphia in the US, while London, Cambridge, and Oxford dominate in the UK. Remote work has reduced constraints, but understanding these hubs helps candidates target employers effectively.

The Future: Why Demand Will Persist

Three converging trends ensure regulatory affairs will remain a high-growth field through at least 2035. Pharmaceutical innovation is accelerating, particularly in personalized medicine, gene therapies, cell therapies, and biosimilars. Regulatory complexity is increasing as agencies adopt AI governance frameworks and big data strategies. And global harmonization remains incomplete, requiring experts who can navigate diverse requirements across markets.

Making the Transition: Practical Steps

For healthcare professionals like Ihsan Mahmood seeking better work-life balance, begin by researching how your current skills translate to regulatory work. Consider entry-level regulatory affairs associate positions at biotechnology firms or CROs, where pharmacy backgrounds are highly valued. Target starting salaries of £30,000 to £40,000 in the UK or $63,000 to $75,000 in the US with expectations of reaching £50,000 to £60,000 or $95,000 to $110,000 within three to five years.

For recent science graduates uncertain about career direction, investigate regulatory affairs master's programs or certificate programs that provide structure and industry connections. Alternatively, complete micro-credentials through platforms like TryMarcus.com to demonstrate interest and foundational knowledge before applying to entry-level positions. Network actively on LinkedIn with regulatory professionals, join Regulatory Affairs Professionals Society student chapters, and attend industry conferences.

For career switchers from project management, quality assurance, or compliance roles, leverage transferable skills while acquiring pharmaceutical-specific knowledge. Emphasize organizational abilities, document management experience, and compliance backgrounds. Apply broadly to contract research organizations and regulatory consulting firms, which value diverse professional histories.

The Sustainable Career

Ihsan Mahmood's transformation from burned-out hospital pharmacist to thriving regulatory affairs specialist represents more than individual success. It illustrates how pharmaceutical regulatory work offers what many professionals seek: meaningful contribution to healthcare without the physical and emotional toll of clinical practice, competitive compensation without medical school debt, intellectual challenge without laboratory constraints, and lifestyle flexibility without career stagnation.

"When I tell former colleagues I work in regulatory affairs, most have never heard of it," Mahmood reflects. "But when I describe what I do and how I live now, they're always interested. I still help bring medications to patients. I still use my pharmacy training. But I do it from home, during normal hours, for better pay, and with much less stress. It feels like a secret that more people should know."

That secret is becoming more visible as AI transformation accelerates pharmaceutical innovation while creating rather than destroying regulatory careers. For those willing to acquire the necessary knowledge, the opportunity remains wide open. The industry's shortage of regulatory professionals, combined with expanding remote work options and competitive salaries, has created conditions unlikely to last forever.

Key Sources

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