​This post originally appeared on MedScrum.com. Visit for industry news and tips. 

The Art of Perspective Shifting

Regulatory Affairs is a challenging profession. But regulatory professionals who manage the challenge most effectively have mastered the art of perspective shifting.

There are so many players—colleagues, other departments, managers, 3rd party registrars, regulatory authorities, customers, and so forth—who have a stake in the advice regulatory professionals give and the decisions they make. Yet how often is it that the needs of these stakeholders are in alignment?

Yes, it would be great if as a regulatory professional you could just arrive at any solution that would satisfy a new regulatory requirement and just leave it at that. Simply move from new regulation to interpretation to solution to implementation. So clean and linear. But, as you know, that’s just not how it works. Each viewpoint a stakeholder holds is valuable--so it has to be taken into consideration. But at the same time, as I've hinted above, each viewpoint tends to be at least to some extent in direct conflict with aspects of the viewpoints held by other affected stakeholders.

Regulatory authorities may want to see you've taken action on a new regulatory requirement that impacts the design and development process followed by your company's software development team, for example. Meanwhile, the team itself still thinks they operate in an R & D department tucked away in the corner of some ivy league university where regulatory responsibilities are viewed as burdensome at best. To get to the right solution,  it's important, therefore, to first clearly understand each stakeholder's unique perspective and their points of conflict. This means not only becoming adept at seeing through the  eyes of each stakeholder, but becoming expert at shifting seamlessly from viewpoint-to-viewpoint so as not to lose sight of an important perspective when pursuing a solution.

From the vantage point of the regulatory authority, the regulatory professional must always ask “are we in fact in compliance?” when evaluating the merits of a particular response to a new regulatory requirement. This is basically the view through the Regulatory Authority’s eyes.

OK, that one’s fairly simple. The next step—bringing into the fold the perspectives of the regulatory professional’s colleagues, boss, and the business as a whole—is where it gets tough. The regulatory professional must now ask:

“To what extent will this solution be disruptive to or otherwise complicate existing workflows?"

"Can the solution be implemented in a more cost-effective manner?"

"Is there a simpler way to achieve the same end?"

"If we add a new step to a process, can we eliminate or simplify another?"

"Is a change even necessary at all (you never know)?"

Then there are the customers, a vital asset to any business. How will they be affected by the potential change? Will the change impact the organization's ability to meet customer requirements? All of these questions must be asked by the regulatory professional all the while keeping in mind the limitations to potential solutions imposed by applicable regulatory requirements. Maintaining compliance is number one, after all. So, while it's unlikely the solution you ultimately arrive at will fully satisfy each stakeholder--let’s be realistic!--by becoming an expert perspective shifter, the solution will at least be one that's been optimized for that specific circle of affected stakeholders.

Expert perspective shifters aren't just good at shifting perspective laterally; these regulatory professionals have mastered the vertical shift, too. Shifting vertically means being able to oscillate between one's everyday duties--writing reports, team meetings, regulatory correspondence, and other day-to-day activities that compete for your attention--and the bigger picture--that is, the organization’s overarching business goals and direction. It's much like the zoom-in/zoom-out functionality of your camera. By being able to engage their own zoom-in/zoom-out functionality, expert vertical shifters are able to maintain a firm awareness of how their work fits in with the business's overall strategy and objectives, and, where a conflict is detected, to adjust accordingly. This skill is especially important when offering regulatory strategy. 

But that’s not the only benefit there is to becoming an expert perspective shifter. As a bonus, by honing their ability to seamlessly and routinely navigate between multiple perspectives, the regulatory professional will naturally grow his or her capacity to empathize. Instead of behaving like a walking encyclopedia of regulatory requirements, the empathetic regulatory professional will feel compelled to listen as much as s/he informs, transforming the regulatory profession into a dynamic and responsive role. Who knows? perhaps a colleague from a different department, drawing on his or her own unique experiences and knowledge base, lands on a solution to a regulatory problem you didn’t think of that you end up using because it's so great (humility helps here too). 

Empathy is also an important tool for getting at what motivates people. And motivated people are more receptive to change (hint: that's important!).  And guess what? Empathetic people tend to be likeable people. Pragmatically, this means teams are naturally more receptive to the input of perspective-shifting colleagues. On a more human level, this means more opportunities for developing meaningful and rewarding relationships with the people you work with everyday. After all, aren't these the people you spend the majority of your time with?