The Skill Regulatory Affairs Must Strengthen First: How We Communicate with Senior Leadership

In Regulatory Affairs, we are highly trained professionals. We understand guidelines, scientific data, risk assessments, and submission strategies. We are precise. We are careful. We are thorough.

But there is one area where our profession still needs significant improvement: how we communicate with senior leadership.

Before Regulatory Affairs can increase its strategic influence, it must first ensure that it is clearly understood. And too often, this is where the gap appears.

Many regulatory professionals come from scientific or technical backgrounds. We are comfortable explaining mechanisms, describing data variability, and presenting complete background information. We value accuracy and nuance. However, executive leaders do not process information in the same way.

Members of the C-suite think primarily in terms of business impact. They focus on risk, timing, cost, opportunity, and reputation. Their decisions affect the entire organization, and they operate under constant time pressure. When regulatory presentations become too technical or too detailed, attention is quickly lost. And when attention is lost, influence disappears.

Clear senior leadership communication does not mean oversimplifying science or ignoring important details. It means organizing information differently. Senior leaders need to understand four essential elements: what decision is required, what the main risk is, how that risk affects the business, and what is being recommended.

Instead of presenting the full scientific journey that led to a conclusion, regulatory professionals must present the conclusion first, followed by the business consequences. The detailed data can always be provided if requested. What matters in the first conversation is clarity of direction.

For example, rather than explaining all aspects of stability variability and regulatory expectations, it is often more effective to say that an additional three-month study is needed to reduce the risk of approval delay, and that without it, product launch could shift by one quarter. This framing connects regulatory science directly to commercial reality.

In global healthcare organizations, regulatory decisions are never isolated technical matters. They influence speed to market, competitive positioning, revenue forecasts, and corporate credibility. When regulatory messages are unclear, leadership may underestimate risks or misunderstand timelines. Clear communication is therefore not a soft skill; it is a form of risk management.

Once clarity is established, strategic influence becomes possible. Regulatory Affairs can then move from being seen as a function that reacts to problems to one that actively shapes decisions. It can evolve from policy interpreter to strategic advisor. But this transformation cannot happen if communication remains overly technical or unnecessarily complex. The first step is simple but powerful: speak the language of business without losing scientific integrity.

Before entering the next senior leadership meeting, it is worth asking a few direct questions. Can the key message be explained in three minutes? Is the business impact immediately clear? Is the recommendation explicit? If the answer is yes, then Regulatory Affairs is not only protecting compliance; it is contributing to leadership.

Clarity is not a reduction of expertise. It is the highest expression of it.