Regulatory Intelligence 101: Key Roles, Responsibilities & Approaches

Jessica Donohue

When it comes to regulatory intelligence, change is the only constant. Yet keeping up is more complicated than it seems.

Lack of compliance is a non-starter for organizations in all industries, but regulatory standards evolve quickly and often. Regulatory intelligence is the function that keeps businesses aware of and adaptable to changes as they arise.

Though this does involve immense amounts of information, it’s more than managing data. Whether or not organizations have mastered regulatory intelligence can make all the difference between staying compliant and making costly slip-ups.

Here’s what businesses need to know about regulatory intelligence to stay ahead.

 

What Is Regulatory Intelligence?

Regulatory intelligence is an active and important member of the governance, risk and compliance puzzle. Regulatory information is the public and private data organizations can use to monitor any changes in regulations, but it’s the “intelligence” piece that transforms that data into a competitive advantage for the organization.

This function includes managing data and analyzing both public and private information, then communicating that information across the organization so it can be applied to company procedures and protocols. Though these professionals are always involved in the inner workings of business operations and governance, they also have an impact on the external landscape; they keep their ears to the ground for upcoming regulation changes as well as future guidelines or policies.

When regulatory intelligence is at its best, it can create an advantage for the organization because it can leverage rapidly-changing information to stay one step ahead of businesses in their industry. This all starts with the right professionals.

 

Roles & Responsibilities of Regulatory Intelligence Professionals

When many businesses think of regulatory intelligence professionals, they think impact analyses. However, the modern professional is actually involved in all levels of the organization, from the boots on the ground implementing new policies and procedures all the way up to senior leadership.

As regulations have evolved, so have the requisite roles and responsibilities. These also vary by industry; professionals working in healthcare have to keep up with a very different set of standards than those in financial services. But no matter the industry, all regulatory intelligence professionals must be able to:

  • Gather and analyze large amounts of data
  • Understand a wide array of products and technologies
  • Strategize on how to implement regulation changes organization-wide

Regulatory Intelligence in the Pharmaceutical Industry

The pharmaceutical industry is one of the world’s most regulated, which is why regulatory professionals are always in high demand. Finding, creating, manufacturing and distributing medications each have their own set of regulations, all of which often change to keep up with public health and safety.

In pharmaceutical regulatory intelligence, it’s the professionals that must stay in touch with regulators, ensuring that their organization remains compliant. This requires them to be involved at all phases of the drug development lifecycle, not just once development is complete. Effective professionals working in pharmaceuticals need to cultivate end-to-end involvement to ensure their organization follows the proper regulations every step of the way.

Regulatory Intelligence in Financial Services

The financial services industry is notorious for ever-changing regulations. During the pandemic, for example, regulatory bodies eased regulations to give financial institutions more flexibility through the crisis; those regulations then inevitably tightened once the initial crisis had passed.

This ebb and flow of regulations puts financial services regulatory intelligence professionals in high demand–and at a high cost. Financial institutions have to adapt quickly, which starts with nimble regulatory intelligence professionals who can set the strategy to ensure that all changes are both necessary and beneficial.

Medical Device Regulatory Intelligence

Medical devices are life-giving for patients around the world, so it’s no wonder that this industry is highly regulated. These standards also shift depending on the type of device; regulations are pretty cut and dry for Class I, non-sterile devices, but these standards are infinitely less so for devices that are high risk, implanted, electronic, sterile and connected to software.

Regulatory intelligence in the medical device industry is also known for employing small teams, so these professionals often have to do a lot with few resources. The challenge, then, is not only keeping up with changing standards, but also staying on top of a huge amount of information.

 

Approaches to Regulatory Intelligence

Though compliance is non-negotiable, regulatory intelligence involves so much more than ensuring the organization is following all industry standards. Think of the regulatory landscape like an onion: there are countless layers, all of which professionals need to peel back to reveal how they can make their product or business competitive.

This begins with a map of the regulatory landscape, which details standards set forth by regulators, trade associations and other major industry players. Doing so also requires massive amounts of information, which can be gathered using two different approaches: passive and active.

Passive Approach

The passive approach to regulatory intelligence leans heavily on publicly available information. Under this approach, professionals constantly collect, analyze and disseminate data that’s available to the public.

Though this approach may be less targeted, it also takes less time and doesn’t require as much specialized knowledge, especially since none of this information is confidential. A passive approach is well suited to broad trends, potential risks and new developments like changing legislation.

 Pros and Cons of a Passive Approach to Regulatory Intelligence
 Pros  Cons
  • Requires little specialized knowledge
  • Appropriate for identifying broad trends
  • Leans heavily on publicly available information
  • Demands continuous data collection, analysis and dissemination
  • Less targeted

 

 

 

 

 

 

 



Active Approach

As the name implies, the active approach requires organizations to seek out information relevant to them. This data is often confidential, and finding it requires specialized knowledge and strong connections to major players in the industry.

Successfully executing an active approach requires solid contacts, the ability to conduct interviews, handling confidential documents and sources and even surveillance. Organizations will benefit from an active approach when they need more specific intel around a target organization, regulatory developments or situation.

Pros And Cons Of An Active Approach To Regulatory Intelligence
Pros Cons
  • Requires specialized skills and solid industry contacts
  • Data collection includes interviews, surveillance and more, making it time consuming 

 

 

 

 

 

 

 


3 Components of Regulatory Intelligence

Though regulatory intelligence looks a little different from industry to industry and even company to company, effective strategies require three components: monitoring, analysis, and strategic action.

1. Monitoring Changes in Regulations

To adapt to regulatory changes, an organization first needs to know about them. That’s where monitoring comes in. This begins with mapping the current regulatory landscape: what is the current climate surrounding regulations, and what changes may be on the horizon?

This requires maintaining what can feel like an exhaustive list of resources, from newsletters to websites to trend alerts. Regulatory and compliance tools can help automate this process, making it easier to quickly identify regulatory changes.

2. Analyzing Information

Gathering data is only the beginning. Regulatory professionals are heavily involved in strategizing changes in response to regulatory developments. To do this, they must analyze all the information they gather to know which trends and changes are worth responding to.

This might include filtering out irrelevant data, flagging information that might be of use to the organization and synthesizing input from a wide variety of sources. Regulatory intelligence teams can then use these reports to help their organizations take action.

3. Recommend Strategic Action

Monitoring and analyzing data should contribute to a plan. This plan should feature strategic action items an organization can take in response to industry trends and developments. It’s up to regulatory intelligence professionals to identify the most practical way forward for their organization, which often requires communication with different internal stakeholders. 

This is also an ever-changing process. Organizations should expect to adapt as regulations do, the frequency of which can vary depending on the product and target market. Investing in a strong regulatory intelligence team will ensure businesses remain compliant no matter how much regulatory priorities shift.

 

Regulatory Intelligence Solutions

Regulatory intelligence is a critical business function, yet it’s also one of the most time-consuming. Teams have to monitor vast amounts of data across a wide variety of sources, and that’s before they analyze each and every one to identify which changes their organization should adapt to.

Regulatory and compliance tools like Diligent Modern Compliance can automate much of this process, freeing up professionals to develop new business strategies. Diligent Modern Compliance is always monitoring and keeping an eye on industry standards, frameworks and regulations. It also identifies gaps and suggests fixes so organizations won’t get caught in non-compliance. With monitoring and analysis taken care of, regulatory intelligence teams can spend more time on the revenue-saving strategies their organizations need.

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