Job one: changing the traditional mindset
In the fast-moving world of life sciences – a world of exciting, new therapies and devices racing to get to market – the labor-intensive work of RA may seem like a necessary evil. Leaders know that RA eliminates the roadblocks and can speed the approval of a product hitting pharmacy shelves. But they also think of RA workers as foot soldiers fighting from the bureaucratic trenches – the people they need to complete tasks that satisfy demanding authorities but add little to no value to the business.
Regulatory departments typically focus on new discoveries in late clinical trials and those in the approval stage. That focus worked more or less effectively in the past, when parameters were narrower. When legislation wasn't changing at the speed of light. When connected devices didn't pose security threats and businesses could keep track of what entered their supply chains at every step. When data wasn't amassing exponentially. And when the risk of non-compliance didn't mean huge fines, lawsuits, and extensive, costly remediation plans.
Today's RA must keep on top of an intricate network of laws and guidelines across the globe. After R&D and other divisions of the enterprise have moved on, it falls to RA to monitor drugs and device dossiers, including those no longer under patent, wherever they are in the world. RA is always on duty to update files for manufacturing and labeling changes and is looking for omissions and gaps that can result in non-compliance. And when it doesn't have the best tools and the right resources to help them negotiate this territory, trouble occurs that can cause both financial and reputational harm to a firm.
Regulatory teams that recognize this understand they must manage their own change, too. If they want to stay relevant, they must seek out, adopt, and own the technologies that can make them true partners in the business.