Shaping the Future of Regulatory Affairs: Industry Trends on Transformation

The Regulatory Affairs Operations Maturity Benchmarking Survey offers a first-of-its-kind view into how life sciences organizations are modernizing their regulatory functions. Drawing on regulatory insights from 50 senior RA leaders across the US, EU5, and global markets, the report explores the future of regulatory affairs: balancing compliance with efficiency, embracing technology while struggling with adoption, and cautiously exploring the promise of Generative AI. Compliance remains the dominant priority, but the call for greater speed-to-market, scalable operating models, and digital maturity is getting louder. Will RA leaders seize the moment to drive transformation, or will the industry remain anchored in legacy practices?

Major Findings at a Glance

The survey (Fig-1) reveals that the top three strategic priorities for regulatory affairs leaders are enhancing compliance with regulatory requirements, establishing or expanding Global Capability Centers (GCCs), and accelerating time to submissions. Compliance emerged as the most frequently cited number one priority, underscoring the industry’s continued focus on this as an area of improvement. The dynamics of responses across the options reflect an interesting interplay of outcomes to achieve better compliance as the most frequent and faster time to market as the 3rd most frequent response. The leverage of Global Capability Centers and Technology are means to assist in achieving improved compliance and faster time to market. What is most unique is that when evaluating the top 3 responses collectively, 74% responded that the leverage of technology and data integration to improve regulatory processes was one of the most important and the next closest of top 3 responses was Accelerating time to Submissions at 54%. This reflects an importance to technology at some point for most of those surveyed.

When turning from strategy to operational priorities, the story sharpens. The number one operational focus (Fig-2) is maximizing the First Time-Right (FTR) rate of regulatory filings and approvals, signals that leaders recognize speed is valuable only when paired with accuracy and quality. In fact, this response was the overall top response when considering the 1st, 2nd and 3rd selections at with a combined 72%. Expanding regulatory capacity to handle growing submission volumes and reducing time spent on variations followed closely, both pointing to the strain RA teams face as global pipelines expand however when considering the combined 1st, 2nd and 3rd responses together the integration of technology was second overall at 60% of respondents selecting this area. This suggests the focus on technology as a means toward addressing the capacity and first time right requirements in the dynamics of this survey.

The picture comes full circle when looking at top areas for regulatory transformation over the next 12 months (Fig-3). Here, the priorities converge on core “plumbing” functions: regulatory submissions and filings, dossier and document management, and digital data flow with RIM systems. These choices reveal that leaders see the greatest opportunity for impact in the foundational processes that directly determine submission speed, compliance, and scalability. Viewed alongside strategic and operational priorities, it becomes clear that transformation efforts are not yet about peripheral innovation, but about strengthening the backbone of regulatory operations. Leaders signal: for RA to embrace advanced technologies like AI, it must modernize its core submission workflows, document processes, and data flow requirements.

Through the next two survey regulatory insights the adoption priorities and barriers combined provide an interesting aspiration and focus. It is quite commonly known that Efficiency is the metric in focus across the industry, which is triggered by cost constraints, an increasingly intimate awareness that time to market is becoming more competitive and that opportunities to create leverage are increasing as well (Fig-4). In conjunction to this the focus on quality in second place is likewise intuitive and complements the need for integration of systems plus leverage of digital data flows which can improve quality.

Yet, alongside this optimism lies a clear recognition of the barriers that continue to slow progress (Fig-5). The top obstacles to technology adoption however are the identification, integration and preparation of teams through change management. Thise organizations that have a more robust and mature approach and team prepared to leverage technology and ensure it is implemented most effectively will more readily achieve faster time to market, quality, and first time right improvements. To address this, regulatory organizations should look at their operating model and ensure they are either leveraging IT business partners coupled with change and learning & development leaders but additionally ensure that roles to focus on the priorities to drive transformation are created which can improve the process from selection through to the change adoption process. These findings reinforce that AI in regulatory affairs must be supported by strong operating models, technology integration and organizational readiness to deliver measurable business value

Few topics in life sciences today spark as much excitement, and caution, as generative AI. The evolution of AI in regulatory affairs is creating new opportunities to improve compliance, productivity and decision-making, although enterprise adoption remains in its early stages (Fig-6). When asked about the current state of GenAI adoption, nearly half of respondents (48%) reported that they are actively experimenting but expect it will take more than six months to go live. Another 24% are experimenting with shorter timelines of less than six months, while 24% have yet to start. Strikingly, only 4% of organizations say they are already using GenAI in regulatory affairs, highlighting just how nascent adoption remains despite the buzz.

The picture sharpens when focusing specifically on closed-system, enterprise-grade GenAI solutions (Fig-7). Here, just 10% of RA teams report active use, while nearly half (46%) have piloted or tested such solutions. Another 42% are still exploring their options, underscoring that most organizations remain in the early discovery phase. Encouragingly, only 2% of respondents say they have no plans to use GenAI in closed systems—indicating that adoption is not a question of if, but when and how.

Submissions management along with publishing combined continue to make up the backbone of regulatory operations, and the survey highlights both the progress and persistent pain points in this critical area. When asked about the biggest challenges, leaders most often cited the use of technology for real-time collaboration and review of submission documents (36% ranked it as the top challenge and even across the top 3 choices this was a combined 60%), followed closely by the need for a RIM to manage dossiers and related documents (28% and when looking at the top 3 choices here also this camp up at 48%) (Fig-8). Strategic planning based on market requirements and dossier availability also ranked highly, emphasizing the tension between content management and planning and oversight of the process. These findings suggest that despite investments the approaches in the process provide a means toward content but the need for more collaboration in content and plans is an opportunity.

Looking at the current and anticipated levels of regulatory submissions automation, the results reveal a story of cautious but determined progress (Fig-9). Today, most organizations sit in the 20–40% automation range, with only a small fraction reporting advanced use. However, expectations for the next 12 months show a strong upward shift, with nearly 38% of respondents aiming for at least 40% automation and a 40% - 60% automation expectation in a combined 76% of respondents. The data suggests that leaders recognize automation as central to improving speed, consistency, and submission quality and the desire to do this quickly. These findings suggest that regulatory submissions automation will remain one of the highest investment priorities as organizations pursue faster, first-time-right submissions.

What stands out is the clear gap between ambition and maturity. While nearly 40% of leaders expect to reach 60% automation within the next year, the majority are still operating at a workflow management stage, far from advanced digital enablement (Fig-10). This contrast signals both optimism and urgency - leaders recognize automation as a lever for speed and quality, but their starting point suggests the journey may be more incremental than they expect. The presence of early AI/ML experimentation (14%) shows momentum, yet also underscores how much transformation remains before intelligent automation becomes mainstream in submissions management.

Labeling has long been a sensitive area in regulatory affairs because it directly impacts both compliance and patient safety, and the survey confirms it remains a top focus for transformation. When asked about their current labeling management practices, the most frequently cited priority was harmonizing labeling content across regions (30% ranked it as the most important), reflecting the ongoing struggle to balance global consistency with local compliance requirements (Fig-11). What is interesting is that respondents also highlighted patient-centric approaches such as readability and clear language (20% rank 1), signaling an industry-wide shift toward making labels more accessible to patients, not just regulators. Other practices such as defined standards for label language, competitive label evaluation, and the use of technology for traceability or change tracking scored lower, suggesting that while these approaches are recognized, they have yet to become widespread.

The automation picture in labeling tells an interesting story (Fig-12). Currently, most organizations report automation levels clustered around 20–40%, but the outlook for the next 12 months is far more ambitious, with a significant share of respondents expecting to reach 60% or even 80% automation. This signals that labeling is becoming a major candidate for digitization, as leaders seek to reduce manual rework and improve traceability across global markets.

However, the maturity profile highlights a familiar tension between ambition and reality (Fig-13). Today, only 2% of organizations report extensive use of AI/ML in labeling, with the majority still relying on workflow management (30%) or rule-based automation (28%). A substantial portion (26%) have started experimenting with minimal AI/ML, suggesting early momentum but not yet widespread adoption. This gap reflects both the complexity of labeling—which requires balancing scientific accuracy, regulatory mandates, and patient understanding—and the organizational challenge of moving beyond pilot initiatives.

Publishing, the critical last step of regulatory submissions, is increasingly becoming a focus for automation and outsourcing as organizations seek to balance accuracy, compliance, and speed. The survey results show that current automation levels are concentrated at the 40–60% range, with 42% of respondents reporting 40% automation today and 24% at 60% (Fig-14). The outlook for the next 12 months, however, suggests an ambitious leap forward: nearly half of respondents expect to reach 60% automation, and close to one in five anticipate 80% or higher. This shift reflects the recognition that publishing, with its highly structured and repetitive tasks, is well-suited for automation-driven efficiency gains.

The maturity profile of automation reinforces this narrative (Fig-15). While only 2% of organizations report extensive AI/ML use in publishing today, a striking 34% already report minimal AI/ML adoption, with another 34% operating at the rule-based automation stage. This is one of the highest levels of early AI/ML experimentation across RA functions, suggesting that publishing is an early test bed for scaling intelligent automation. At the same time, 22% of respondents remain at the workflow management stage, highlighting that while progress is underway, there is still a wide spectrum of maturity across organizations.

Regulatory writing plays a pivotal role in shaping how data is communicated to regulators, and the survey reveals a blend of traditional practices and emerging innovations shaping the function today (Fig-16). Among current practices, the top priorities were review and oversight of external vendors/suppliers (24% rank 1), alongside use of technology to automate sections of regulatory documents (20%) and establishing best practices for authoring and review (20%). These results highlight the delicate balance RA leaders are trying to achieve—ensuring quality and compliance through structured oversight, while cautiously experimenting with automation to reduce the manual burden of drafting lengthy, complex documents. Interestingly, standardized templates and clear communication of document ownership also scored high, pointing to the enduring importance of consistency and clarity in regulatory writing processes.

The automation outlook in regulatory writing suggests a function on the cusp of significant change (Fig-17). Today, most organizations report automation levels of 20–40%, with limited penetration of advanced tools. However, projections for the next 12 months show a striking shift: half of respondents expect to reach 60% automation, and nearly one in five anticipate 80% or higher. The maturity profile reinforces this ambition (Fig-18), while a quarter of organizations remain at workflow management, a notable 32% already report minimal use of AI/ML in regulatory writing, and a small but growing share (4%) claim extensive AI/ML adoption. This makes regulatory writing one of the more advanced areas of experimentation with intelligent automation, likely because of the clear potential to auto-generate or pre-populate sections of documents from structured data.

Life science regulatory intelligence & strategy is often viewed as the “bridge” between product development and market access. Increasingly, organizations are investing in life science regulatory intelligence & strategy capabilities and regulatory affairs intelligence to make faster, evidence-based regulatory decisions. When asked about the key drivers of regulatory strategy development, leaders highlighted cross-functional collaboration (27%) and early engagement with regulatory authorities (24%) as the most critical factors (Fig-19). This underscores the reality that regulatory strategy is no longer crafted in isolation; it depends on alignment with R&D, commercial, and clinical teams, as well as proactive dialogue with health authorities. Interestingly, while speed-to-market remains a goal, only 18% cited routine review of regulatory pathways as the top driver, suggesting that leaders see collaboration and authority engagement as the more powerful levers for success.

But when we turn from drivers to enablement, the picture becomes more complicated (Fig20). Automation levels in regulatory strategy remain relatively modest. More than half of respondents report operating at just 20% automation today, with only incremental shifts expected in the next 12 months. While 38% aspire to reach 40% automation, and 28% aim for 60%, the maturity profile shows that the majority are still anchored in basic tools (36%) or workflow management systems (40%) (Fig-21). Very few have advanced into AI/ML territory, with only 10% reporting minimal adoption and none reporting extensive use. This reflects a critical disconnect: while regulatory strategy is recognized as a high-value function, it remains heavily reliant on human expertise and manual processes rather than scalable digital systems.

The survey findings paint a clear picture of a function in transition. Compliance remains the non-negotiable foundation, but leaders are equally focused on building scalable operating models and accelerating submissions to meet business demands. Operationally, the emphasis on first-time-right filings and rising submission volumes reflects a pragmatic focus: speed is valuable only when paired with accuracy.

Across functions, we see a consistent pattern—ambition outpacing maturity. Leaders are betting on automation to transform submissions, labeling, publishing, and writing, yet the maturity profiles show that most organizations are still operating at workflow management or early AI experimentation. Additionally, the frictions preventing adoption of technology demonstrate that regulatory organizations may need to ensure there is sufficiently trained resource dedicated to the strategic plans toward adoption and implementation of changes in process, data, digital, and AI. A strategic governance to enable selection, implementation and adoption. Lastly, the leverage of partners that are truly strategic can bring that structure and rigor in planning, value prioritization, roadmap and complementing process domain + technology expertise to execution can ensure more effective outcomes as well.

Perhaps the most telling signal comes from Generative AI. Almost every RA team is exploring it, most through closed-system pilots, but very few have moved to enterprise adoption. This reflects both the caution and the opportunity ahead—RA may not lead the first wave of GenAI adoption in life sciences, but it is positioning itself to adopt responsibly, where the stakes of compliance and data integrity are highest.

The overall message is clear: regulatory affairs is at an inflection point. Leaders must harmonize three imperatives—compliance, scalability, and agility—while closing the gap between ambition and execution. Those who succeed will not only reduce risk and accelerate access but also redefine RA as a strategic enabler of innovation and market success, rather than a back-end compliance function. The challenge, and the opportunity, is to turn today’s fragmented progress into tomorrow’s operating model.

Together, these regulatory insights reveal that the future of regulatory affairs will depend on successfully combining human expertise with AI in regulatory affairs, regulatory submissions automation, and stronger life science regulatory intelligence & strategy capabilities.

If you would like to dig deeper into any of the topics covered in this report, explore function-specific regulatory insights, or access customized slices of the survey data relevant to your organization, our team would be glad to collaborate. Reach out to us to continue the conversation.

The survey drew regulatory insights from 50 senior regulatory leaders (Fig-22) across global, regional, and local functions (Fig-23). Respondents represented large, mid-sized, and emerging pharma organizations (Fig-24), ensuring a balanced perspective across the RA maturity curve. Geographic coverage (Fig-25) spanned North America, EU5, and global roles, providing an international outlook on operational trends. Participants oversaw submissions management, labeling, regulatory writing, regulatory strategy, and publishing - functions at the heart of regulatory transformation (Fig-26).