By Brenna D'Alessandro, Managing Consultant, Stevenson Search Partners
Not long ago, regulatory affairs was considered a later-stage function, something companies built out once programs were in the clinic. That thinking has shifted considerably, and the companies moving fastest are often the ones that recognized it first.
One example illustrates it well. Well before building out a fully mature global infrastructure, a global medical device company made a deliberate decision to bring in a Chief Regulatory Officer reporting directly to the CEO. The return showed up not as one defining moment, but as a cohesive development and commercialization strategy, stronger cross-functional alignment, increased investor and stakeholder confidence, and fewer downstream course corrections as the organization expanded internationally. That is what a successful early regulatory hire can deliver: a series of better decisions that compound overtime.
It also reflects how fundamentally the regulatory affairs function has evolved. What was once a downstream execution role embedded within R&D has become a strategic function that companies are staffing earlier, compensating more competitively, and in some cases elevating to report directly to the CEO.
A Function Reshaped by Complexity
The shift toward earlier regulatory investment reflects how the development landscape has changed. Companies are now operating across novel modalities including ADCs, mRNA platforms, cell and gene therapies, and complex biologics, each introducing new considerations around toxicity, manufacturing, and long-term patient monitoring. Regulatory expectations are more rigorous, less predictable, and more variable across global agencies.
Historically, many biotech companies waited until late preclinical or even Phase 2 before building in-house regulatory capabilities. Today, that investment is happening around IND-enabling work, at the transition into the clinic, or even earlier. Early decisions carry greater weight in this environment. Experienced regulatory judgment can shape clinical design, endpoint strategy, agency engagement, and CMC planning in ways that build cumulative advantage, while missteps have become significantly more costly to unwind.
When a company invests in regulatory leadership at the preclinical or early clinical stage, it signals that the organization is thinking beyond the next milestone. It reflects development rigor, not just scientific novelty, and an understanding that regulatory strategy should be integrated with clinical, technical, and corporate strategy from the outset.
When Regulatory Reports to the CEO
While not the default in many companies, regulatory affairs reporting directly to the CEO is becoming more common than it was a decade ago, particularly in emerging biotech. That reporting line changes the role materially. The person is no longer just leading regulatory affairs. They are helping shape enterprise strategy, which requires broader judgment, stronger communication skills, and the ability to translate complexity for boards, investors, and peers. Not every strong regulatory operator is the right fit for that structure. The reporting line elevates the role, but it also raises the bar considerably.
Compensation Has Moved Accordingly
Compensation for senior regulatory leaders is now increasingly comparable to R&D leadership. The market has become competitive, and the available pool of leaders who combine deep technical expertise with strategic enterprise thinking and cross-functional influence is relatively limited. Senior regulatory leaders now command packages that can exceed a $400k, plus bonus and equity. For early-stage companies, that is a meaningful investment, which is why we often advise clients to evaluate whether a full-time executive is needed immediately or whether a highly experienced consultant can provide the right support in the near term. The priority is ensuring strong regulatory thinking is embedded early, regardless of structure.
Where the Function Is Heading
Regulatory affairs is moving closer to the center of decision-making, and that trajectory is unlikely to reverse. The strongest leaders in this space will be those who can connect agency strategy to broader corporate outcomes: development efficiency, capital strategy, partnering readiness, and commercial ambition.
For companies building their teams today, the most important shift is knowing that regulatory leadership is not something to layer in later. The organizations that treat it as a value-creation lever from the start are consistently better positioned to move faster, make better tradeoffs, and build more credible development programs.
