There is a particular kind of frustration that happens inside life sciences TA teams that nobody talks about openly. You post a Director of Regulatory Affairs role. You get applications. You screen them. You send the strongest ones to the hiring manager. And the feedback is always some version of the same thing: close, but not quite right.

So you post again. You add more requirements to the job description. You expand the search geographically. You try a different job board. You maybe bring in a contingency agency that sends you twenty more profiles that are also close, but not quite right. Six months pass. The role is still open.

Here is what is actually happening. The candidates you want — the ones with the right combination of therapeutic area experience, regulatory strategy background, FDA relationship depth, and the judgment that comes from having navigated a real submission under pressure — they are not applying anywhere. They are not on job boards. They are not updating their LinkedIn profiles. They are heads down in their current roles, doing exactly the kind of work that makes them the person you want.

This is not a pipeline problem. It is a sourcing model problem. And it is the reason so many critical Regulatory Affairs searches fail on timelines and settle on candidates who are merely adequate instead of genuinely excellent.

The Passive Candidate Reality in Regulatory Affairs

Regulatory Affairs is one of the most talent constrained disciplines in the life sciences sector. The reason is structural. You cannot grow a Regulatory Affairs professional quickly. The experience that makes someone genuinely valuable — an IND, an NDA, a BLA, a Type A meeting, a Complete Response Letter — takes years to accumulate. It cannot be simulated in a training program.

That scarcity means the people you want are almost never available through inbound channels. In my experience working this market for more than two decades, the candidates who are actively job searching in Regulatory Affairs are almost always in one of two situations: they have just been laid off in a restructuring, or they are leaving a role because something has gone wrong. Neither of those is the ideal starting point for a critical hire.

The candidates who are actively job searching in Regulatory Affairs are almost always in one of two situations: they have just been laid off, or they are leaving a role because something has gone wrong. Neither of those is the ideal starting point for a critical hire.

The people you actually want — the Director who has led three successful submissions, who has a relationship with the review division, who has navigated a manufacturing change in the middle of a review without triggering a refuse to file — are working. They may have a passing curiosity about the market, but they are not going to fill out an application on your careers page. They are going to need someone to reach them directly, make a compelling case, and make them feel like the conversation is worth their time.

Why Job Descriptions Make the Problem Worse

Most Regulatory Affairs job descriptions are written in a way that actively filters out the best candidates. They are written for compliance purposes, not for attraction. They list every possible competency the hiring manager might want in an ideal world, which creates a profile that essentially does not exist in the talent market.

I have seen postings for Director level Regulatory Affairs roles that require fifteen years of experience, direct FDA submission experience across three therapeutic areas, existing relationships with CDER and CBER, and a willingness to work on site five days a week in a market with no local talent pool. Every one of those requirements eliminates a category of excellent candidates before the search even starts.

The more important problem is what happens psychologically. When a strong Regulatory Affairs professional who is happily employed sees a job description that reads like a checklist of impossible requirements, they do not apply. They assume they will not be considered, or they assume the company does not know what they actually need. Either way they scroll past.

This is why intake calibration is so important. Before we source a single name, we need to understand what is truly required versus what would be nice to have, which therapeutic areas are genuinely non negotiable, what the submission history of the company looks like, and what kind of environment and leadership style has made people successful in Regulatory Affairs at this organization before.

What Proactive Headhunting Actually Looks Like

When we run a Regulatory Affairs search, the first thing we do is build a target company list based on the intake conversation. Which companies are in the same therapeutic space? Which ones have the same submission complexity? Which ones have the same stage of development profile that would make someone's experience directly transferable?

That list typically has thirty to fifty companies on it. We are looking for Directors and Senior Directors who have been in their current role for two to four years — long enough to have accomplishments to discuss, not so long that they are unlikely to move. We are looking for specific submission experience, specific agency experience, and specific milestones that match what our client needs.

This takes longer than posting a job and waiting for applications. The first engagement to qualified conversation is typically seven to ten business days. But the quality of the candidates at the end of that process is not comparable to anything you will find through inbound sourcing. These are people who have been carefully identified, thoughtfully approached, and genuinely interested in the opportunity — not people who applied because they were bored on a Tuesday afternoon.

The Cultural Fit Conversation Nobody Has Soon Enough

Regulatory Affairs leaders tend to have strong opinions about how the function should be structured, how it should interface with Clinical and CMC, and where it should sit relative to the CEO. Those opinions are formed by the environments they have worked in, and they are not always compatible with what a new organization needs.

This is where a lot of Regulatory Affairs hires fail even when the technical background is exactly right. A person who built their career in a large pharma regulatory function with fifty people, dedicated therapeutic area alignment, and a full regulatory operations team will struggle in a twenty person biotech where they are the entire regulatory function. Not always. But often enough that the question has to be asked directly, early, and honestly.

At Eagle, we spend a significant portion of the intake call on this conversation. What does regulatory look like inside your organization today? What does it need to look like in two years? What has made past Regulatory Affairs leaders successful here, and what has caused people to fail? Those answers change who we look for and what we say to candidates when we reach them.

A Note on Compensation

Director level Regulatory Affairs professionals at mid to large pharma companies earn base salaries ranging from $185,000 to $250,000 depending on market, therapeutic area, and stage of company. Senior Directors typically range from $230,000 to $310,000. These ranges have compressed somewhat since the 2021 and 2022 talent market peaks, but they have not returned to 2019 levels.

If your posted compensation range is below the midpoint of this market, you are not going to be competitive for the passive candidates who are thriving in their current roles. You might attract candidates who are leaving difficult situations and willing to take a step back. That is a different search with a different outcome.

This is one of the most important conversations to have honestly at the beginning of an engagement. I would rather tell a client their compensation range is misaligned with the market in week one than deliver a shortlist in week two that they cannot close.

What You Should Expect from a Strong Regulatory Affairs Search

A properly run proactive search for a Director of Regulatory Affairs should deliver a curated shortlist of three to five genuinely qualified candidates within ten business days of search launch. Those candidates should have been personally engaged, not just submitted without a conversation. They should have indicated real interest in the opportunity, not just agreed to a call out of curiosity. And each submission should come with a complete profile that tells you not just what the candidate has done, but why they are the right call for your specific situation and what the risks are.

If you are consistently receiving large volumes of profiles that are technically qualified but not quite right, the problem is almost certainly the sourcing model — not the talent market. The talent is there. You just need a different way to reach it.

J. C. DeTemple
Principal Recruiter & Strategic Talent Partner, Eagle Recruiting Services
TopTalent@EagleRecruitingServices.com · 518-894-9844