Are you working with the right type of Regulatory Affairs professional?

Are you working with the right type of Regulatory Affairs professional?

By Craig M. Audet, Ph.D., Principal Consultant

In looking back at my 3+ decades of experience with the pharmaceutical and medical device industry, I have had the opportunity to facilitate the development of a variety of products, collaborate on a diverse range of regulatory challenges and worked alongside different CEOs. I have always believed that Regulatory Affairs professionals (RAP) can be generally categorized into one of two broad buckets: regulatory policemen and regulatory strategists. Which category does your RAP fit into?

  • How to recognize a regulatory policeman and a regulatory strategist.

Regulatory Policeman (RP): The RP is a non-risk taker and they believe their job is to prevent non-compliance. They are completely comfortable interpreting regulations, guidance documents, etc. as binary – it either can or can’t be done. There is little, if any, room for interpretation. The RP believes that regulations must be followed and they don’t believe in asking the FDA to consider a different path, usually with a justification such as “we don’t want to get FDA upset with us.” These are the folks who loathe to prognosticate, however, if forced to estimate the probability of success on a strategy, will say, “I give it 50/50.” When you probe them for the reason why something can’t be done, they respond with “because the regulations say so” but when you examine the situation further, there is no direct support for that statement other than an obscure regulation or conservative interpretation.

Regulatory Strategist (RS): The RS believes that their job is to find ways to help the company and the teams they serve to meet their objectives. They are working in the shades of grey that exist in many areas of the regulations; for example, where a guidance document says “should” rather than “shall”. They believe their job is not to say yes or no but rather, where possible, to provide the company with several strategies to meet the desired outcome, educating on the risks and benefits of each scenario. This allows the decision to be raised to the appropriate level of management, to make a final, informed decision on which path to take depending on the risk tolerance on that specific issue. 

  • Which regulatory type works best for your organization?

At this point, you may be thinking that I already have my mind made up on which approach I prefer. However, it may surprise you to know that I think both approaches are necessary based on the company’s philosophy on risk-taking, which may differ depending on the subject matter. For example, I once worked for a company where the CEO’s edict on advertising and promotion was that we never receive a FDA compliance letter. In this situation, the RP is a perfect fit and the RS would feel constrained and stifled. Compare that to another CEO whose viewpoint was that if you are not getting compliance letters you are not “pushing the envelope.” The RP would be paralyzed by the realistic likelihood of negative FDA correspondence and the RS would likely be motivated to map multiple options. Parallel examples can be found in other regulatory disciplines such as CMC, development, labeling, etc. In many cases, it helps to have both types of RAPs at your company as a check-and-balances approach or to address varying levels of risk tolerance in different areas of the company. 

  • Effectively working with your RAP.

The first step in working effectively with your RAP is to determine the philosophy of your company regarding risk-taking as a whole or by subdiscipline (e.g., individual development team) and see if you have a match. This should take the form of an open and candid discussion so any divergent perspectives can be identified and managed. In my experience, it is very difficult and time-consuming to convert one type of RAP to the other, so ideally this should be part of the initial hiring process. It is also my experience that a positive match can lead to a significant reduction in disagreements and frustration between team members with corresponding increases in teamwork and productivity.

In conclusion, matching your company’s risk tolerance to the type of RAP you need can greatly increase productivity and positively influence team relationships.