The consequences of developing a product without early and frequent involvement from Regulatory Affairs are severe. Consumer safety, recalls, and class action lawsuits make up some of the biggest risks, but loose oversight can also result in costly delays and wasted company resources.
Regulatory Affairs is about making the right decision to protect the company and consumers. The job is rooted in gathering, absorbing, and applying direct guidance from outside bodies, including regulatory authorities, industry groups, and consumers.
The information isn’t always clear, nor is it consistent across regions; sometimes determinations have to be made without complete certainty. Good judgement requires diligence and a knack for details. Nuances can mean the difference between failure and success, and sometimes little items hold up major projects.
At times, oversight appears to run contrary to business priorities. But regulatory affairs isn’t necessarily tedious or adversarial. When done correctly, regulatory compliance is an incredibly rewarding process that does more than keep consumers and companies safe; it helps establish strong relationships and quality brands.
Because of the unique way Regulatory Affairs oversees product and marketing claims, there’s an opportunity for the role to develop internal bonds within an organization. Good compliance happens early and often, so this direct involvement should focus on strong communication and positive consultation with process owners.
When Regulatory Affairs is engaged from the start, process owners feel comfortable asking questions and heeding advice. While the inclusion of regulatory affairs may seem cautious, it encourages processes to be done right from the get-go. Having precise and detailed oversight allows an organization to anticipate and avoid challenges before they manifest.
Sometimes the involvement of Regulatory Affairs creates friction and the appearance of disparate business priorities. While process owners and Regulatory Affairs may appear out of sync, the end goal of these engagements is always to protect consumers and the company. Working through conflicting priorities helps stakeholders assess the layers of risk and make good decisions. Once these factors have been clearly identified, parties can resolve items and achieve compliant business objectives.
Internal engagements also present training opportunities, giving Regulatory Affairs a chance to ensure best practices are current and adhered to. This kind of leadership places regulatory affairs in a unique position to consult with parties across the company.
A lot of guidance will come from external sources, including regulators, academia, national and international organizations, and consumers. Building and maintaining relationships with various outside entities allows for a better understanding of their perspective on regulations, making it easier to interpret their expectations. When it’s time to evaluate risk and validate a claim, especially one without complete certainty, having long-standing knowledge of external sources and their position will inform the assessment.
These external forces are strong influencers. Their input informs more than just claims validations, they’ll help establish training practices and compliance processes. As such, it’s important to identify which external relationships should be routinely engaged. Being able to ask questions of the appropriate external source will ensure compliance decisions are correct.
Both internal and external dynamics culminate in a unique way for Regulatory Affairs.
The convergence of these groups means that Regulatory Affairs becomes a conduit for brand. The external guidance and internal business priorities become actualized as Regulatory Affairs helps process owners validate claims and products. This influence shapes the brand, including specifics about the product and the campaign, but also generates intangibles, like reputation.
Whether it be new laws or marketing proposals, the Regulatory Affairs team is always absorbing and processing information. For some, being able to regularly dig into new areas and expand their knowledge on subjects is incredibly rewarding. These insights help to broaden individual perspectives and can often be applied to other circumstances.
This comprehension serves as another opportunity to gain a deeper understanding of the brand, its offerings, and its voice. Having accumulated knowledge only strengthens the product or claim, making it easier for Regulatory Affairs to offer complete and holistic guidance.
It’s always important for Regulatory Affairs to have direct access to information. Sometimes it’s hard to manage so many inputs or stay current with internal and external relationships. Tools that aid in tracking information, processes, and brand at all stages grant access to current and correct information. For example, Trace One's Food News Monitoring System (FNMS) in the Trace One Regulatory Compliance keeps track of global regulatory environments, alerting users directly to changes that will affect their products. This kind of immediate and complete knowledge helps Regulatory Affairs to organize and prepare an internal response.
By using technology to break down silos and create visibility, Regulatory Affairs can harness knowledge from a variety of sources and make informed decisions.
There are tangible consequences for poor regulatory compliance. Being involved early and often results in positive outcomes for the business and consumers. Establishing and maintaining strong internal and external relationships will improve the speed and accuracy of decisions, helping to keep everyone protected. Technology bridges gaps and silos in knowledge and relationships, making it easier to reach the right decision.
To learn more about compliance tools or other benefits of strong regulatory affairs practices, schedule a demo with us today