Human-centred regulatory affairs

In regulatory affairs, we need a new way of working – one that is human-centred, cross-functional and insight-driven.

We foresee that automation will enhance the role of experts to better focus on dialogue with regulators, and regulatory strategies will be intelligence-driven and informed by social listening.

New teams will need new skills in data management, insight analysis and digital health. This will put regulatory affairs in a strong position to meet the demands of R&D and lift the strategic influence of regulatory affairs to the next level.

Going beyond technology – focus on the human aspect

Many life science companies take a technology-led approach to creating value in regulatory affairs. The current wave of document management platform roll-outs such as Veeva Vault, ArisGlobal’s LifeSphere and Amplexor’s LSSuite will establish a technical foundation for information management and business processes. However, technology alone will not deliver the desired improvements in productivity, quality and expert effectiveness.

We must focus on the human aspects in newly digitised regulatory functions to realise the potential business benefits. Leaders of regulatory affairs need to ask how they can reorientate specialists to higher value tasks; what new ways of working will drive empowerment and innovation; and how to retain and attract the best regulatory affairs talent.

The role of regulatory affairs

The prime objective of regulatory affairs is to get products successfully registered and approved by the appropriate health authority. A large part of the job is to plan and manage submission dossiers, including collecting data and preparing documentation.

Regulatory teams must also analyse global and local policies and regulatory trends, develop regulatory strategies and manage and track regulator interactions.
In regulatory affairs, there is a dichotomy in the fact that practitioners are highly trained scientists, yet the job may demand a disproportionate amount of time performing repetitive, document-checking tasks.

Therefore, it is crucial to free up time and redesign the role of regulatory specialists to realise the return on investment in new technology.

Regulatory affairs is changing

When we work with regulatory affairs, we aim to “do more with less”, creating capacity and agility to meet the increased productivity of R&D and handle innovation.

At the same time, regulatory teams are now strategic advisers to R&D and medical functions, encouraging good stewardship for products whilst maintaining local regulatory expertise and relationships with health authorities.

How can regulatory affairs create more value?

Future-oriented regulatory affairs functions share certain capabilities foundational to create broader value for their business. Enabled by technology, these capabilities, however, only become effective through human experts working in close concert with counterparts and acting on insights.

Focusing on the following areas will enable regulatory affairs teams to unlock full value from their transformations.

Automating lower-value tasks to unlock human potential

A clear pain point for regulatory professionals is the drudgery of repetitive documentation and publishing related tasks.

We can unlock massive potential through automating predictable tasks like formatting, metadata extraction, dossier building and basic quality checks. By limiting expert involvement in such activities, we increase capacity for strategic, complex tasks.

Creating interdisciplinary teams with new skills in data literacy

We need self-organising, interdisciplinary teams to address digital disruption, specifically the approval and licencing of algorithms and digital assets for precision and personalised medicine.

In addition, we need fresh perspectives on what this new way of organising teams means for regulation, product safety and how efficacy is evaluated. New, cross-functional teams will centre on therapeutic areas, bringing together disciplines in regulatory strategy, digital health, clinical, safety, medical affairs, data stewardship and local market expertise.

Proactive health authority exchanges, social listening and intelligence gathering

Continuous dialogue with regulators and policymakers, e.g. the FDA, MHRA, WHO etc., helps bridge industry, customer and regulatory needs.

Effective regulatory teams gather market and regulatory intelligence through “social listening” tools to better understand patients’ unmet needs, behaviour patterns and trends in health issues.

Social listening is about monitoring digital conversations amongst stakeholders (typically in the news and social media) to get insights into what people and groups are saying about their experiences with products.

Social listening provides relevant, voluminous high-velocity data. Therefore, it becomes imperative that we establish a “data-to-insights” process to filter, analyse and summarise the vast quantities of social data to avoid becoming overwhelmed.

Building a shared, insight-driven big picture

The ability to capture and mine data sources around product activity improves the overall regulatory strategy and innovation and will accelerate approvals.

We need to build a common, visual, easy-to-understand submission pipeline for stakeholders to see and thus enable insight-driven decision-making on product strategy.

This means accessing new data sources to support decision-making (e.g. real-world evidence, biomarkers and patient insights), forcing a change in how evidence is evaluated.

Effective forecasting, priority setting and flexible resource management

Accurate forecasting enabling dynamic priority setting and flexible central planning are at the heart of making regulatory affairs effective. This, in turn, helps direct R&D because it explores new modalities (as seen with RNAi in the COVID-19 vaccine design).

Enhanced regulatory resource management makes capacity available for activities of strategic value without risking the licence to operate.

Conclusion

Optimise the regulatory affairs operating model, and embed data literacy for sustained future readiness.

The COVID-19 pandemic accelerated the move towards digitisation and data-driven submissions. The development has opened opportunities to speed up the drug approval process, drive innovation, increase responsiveness in health authority interactions and free up capacity of regulatory specialists to focus on more value-adding activities.

But to achieve the full potential, regulatory teams need a new operating model that creates autonomy in decision-making and insight-inspired creativity and frees up specialists from repetitive tasks.

How Implement Consulting Group helps

Implement Consulting Group can support you in transforming your company into a self-organising, human-centred organisation.

We understand that creating value in regulatory affairs does not stop with the selection and implementation of technology. We can help you develop a future-fit operating model, acquire new data literacy skills and take full advantage of new technologies to unlock the potential of your people.