Building a Nimble, Strategic Regulatory Organization for the Future

Regulatory affairs is being asked to change its role at the very moment complexity is peaking. Development timelines are compressing, global portfolios are expanding, and policy landscapes are shifting faster than ever. At the same time, regulatory teams are expected to move beyond execution and play a more strategic role in shaping decisions across the product lifecycle.

This tension framed a candid discussion at the Indegene Digital Summit 2025 Virtual Edition, where leaders from Pfizer, Boehringer Ingelheim, and Novartis - Joe McLaughlin, Dr. Thomas Seck, and Tim Twells - joined Vladimir Penkrat of Indegene to reflect on what this new reality truly demands. Rather than debating tools or structures in isolation, the conversation surfaced a deeper question many regulatory leaders are grappling with but rarely articulate openly.

If speed, quality, and strategic influence are all non-negotiable, what does a regulatory organization need to look like to deliver all three - consistently and at scale? The insights that followed challenge long-held assumptions about how regulatory teams are designed, led, and enabled for the future.

For years, regulatory strategy and operational speed were treated as competing priorities. Strategy lived upstream, focused on long-term positioning, scientific alignment, and policy interpretation while speed was treated as an execution problem, measured in timelines, submissions, and throughput.

That separation is breaking down.

Modern regulatory organizations are expected to be both strategic and nimble at the same time. Strategy now means aligning regulatory decisions with business priorities, scientific evolution, and portfolio direction, often years in advance. Nimbleness means responding quickly to changing data, shifting health authority expectations, and internal pivots across the product lifecycle.

These capabilities are no longer separable. Speed without strategic intent amplifies rework and risk. Strategy without operational agility stalls at the slide-deck stage. The regulatory organizations performing best are not choosing between the two - they are deliberately designing for both.

And that design question is where the conversation inevitably turns next: if strategy and speed must coexist, how should regulatory organizations actually be structured to enable them, without defaulting to rigid models or false absolutes?

Organizational design has become one of the most contested and often oversimplified topics in regulatory transformation. Debates quickly fall into familiar binaries: centralized or decentralized, global or local, matrixed or agile. These labels are easy to argue, but they rarely survive first contact with real-world complexity.

The reality is more demanding. There is no universally “right” regulatory operating model, because regulatory organizations do not operate in static environments. Portfolio mix, geographic spread, regulatory risk appetite, process maturity, and digital readiness all shape what will actually work in practice. Design choices that accelerate one organization can slow another.

What differentiates high-performing regulatory organizations is not structural purity, but clarity of intent. Leaders are becoming explicit about what must be standardized for consistency, scalability, and compliance, and what must remain close to markets to preserve context, judgment, and speed. This clarity reduces friction, shortens decision cycles, and prevents design from becoming an abstract exercise.

As a result, the conversation is shifting. Instead of asking which structure is best, regulatory leaders are asking how work really flows: where decisions are made, who owns outcomes, how expertise travels across the organization, and how accountability is enforced without creating bottlenecks. These pragmatic hybrids may look messy on an org chart but they are often far more resilient in execution.

Centralization plays a critical role in enabling consistency, scalability, and efficiency. It supports common standards, shared platforms, and enterprise-wide regulatory intelligence. It also accelerates the adoption of digital tools and emerging technologies across regulatory operations. However, over-centralization introduces risk.

Local market expertise, especially in areas like labeling, post-approval changes, and health authority engagement, remains indispensable. Regulatory success often depends on contextual knowledge that cannot be fully abstracted or standardized.

Leading regulatory organizations are adopting hybrid models that centralize capabilities such as data, platforms, governance, and regulatory intelligence while preserving local decision-making authority where it matters most. This balance allows global alignment without sacrificing responsiveness.

As regulatory transformation accelerates, the skills required within pharma regulatory affairs are evolving just as quickly.

Technical expertise remains foundational. But it is no longer sufficient.

Regulatory professionals are increasingly expected to navigate ambiguity, synthesize complex information, influence stakeholders, and communicate risk and opportunity clearly. Cross-functional collaboration, negotiation, and storytelling are becoming core competencies.

Data fluency is another differentiator. Regulatory teams are expected to interpret insights, not just compile information. The ability to work with structured and unstructured data, supported by regulatory intelligence platforms and analytics, is becoming essential for informed decision-making.

Equally important is mindset. Resilient regulatory organizations invest in learning, curiosity, and empowerment, enabling teams to adapt without fear of failure.

Digital tools, automation, and generative AI are reshaping regulatory operations. But technology is not a shortcut to transformation.

Many organizations have discovered that layering new tools onto legacy processes simply accelerates existing inefficiencies. True regulatory innovation requires rethinking how work is done, not just how it is automated.

Language is changing as well. The term “regulatory operations” is giving way to broader concepts that emphasize enablement, integration, and strategic contribution. Technology becomes an enabler of insight, collaboration, and scale not just efficiency.

Culture plays a decisive role. Successful regulatory transformation depends on psychological safety, experimentation, and visible leadership support. Teams need permission to test, learn, and iterate. Without that foundation, even the most advanced tools struggle to gain adoption.

One of the most persistent challenges in regulatory innovation is the gap between experimentation and scale.

Pilot initiatives generate enthusiasm. Proofs of concept demonstrate potential. Yet many organizations stall before enterprise adoption. This “pilot purgatory” reflects gaps in governance, ownership, and measurement.

Progressive regulatory organizations are addressing this by establishing clear frameworks for innovation. These include defined decision rights, structured governance models, and support for controlled experimentation through citizen innovation approaches.

Measurement is evolving as well. Return on investment is no longer viewed solely within regulatory silos. Leaders are assessing impact across development timelines, submission quality, cross-functional alignment, and organizational learning.

High-performing regulatory organizations apply a simple discipline:

Decisiveness matters. Knowing when to stop experimenting and commit to scale is as important as innovation itself.

Resilient regulatory organizations combine strategic foresight with operational agility. They invest in regulatory intelligence to stay ahead of evolving expectations. They design organizational models that balance global consistency with local relevance. They empower talent with both skills and confidence. And they approach regulatory transformation as a continuous journey, not a one-time initiative.

In an environment defined by uncertainty, resilience becomes a competitive advantage. For regulatory leaders, the challenge is no longer whether to transform—but how deliberately, sustainably, and humanely that transformation is executed.