Filling a VP of Regulatory Affairs at a Biotech Consultancy
A life sciences or biotech consulting firm's leadership hires often need to bridge two worlds: deep scientific credibility and genuine regulatory fluency with agencies like the FDA. Finding both in one person is hard, and it's worth running the search deliberately rather than settling for whoever interviews best. Here's a step-by-step approach using either Hunt Club or Bolster.
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Which half of the job matters more right now?
Write down whether your firm's more urgent need is deep scientific credibility that clients respect in the room, or hands-on regulatory submission experience that keeps engagements moving through agency review. Few candidates are equally strong at both, and being explicit about which matters more for this particular seat will sharpen your search on either platform.
If scientific credibility is the priority, Hunt Club's referral model can surface candidates whose reputations are already known within a specific therapeutic area through peer introductions. If regulatory execution is the more pressing gap, Bolster's marketplace lets you browse directly for people with hands-on submission experience, including on a fractional basis.
A useful test: think back to your firm's last two client engagements that hit real friction. If both stalled on the science, prioritize scientific depth; if both stalled on agency paperwork or process, prioritize regulatory execution instead.
Step Two: Match the Engagement Type to the Actual Need
A permanent VP of Regulatory Affairs, best sourced through Hunt Club, fits a firm that needs someone owning regulatory strategy across a growing client roster indefinitely. A narrower need, like guiding one client through a specific submission or building out a regulatory practice before committing to permanent headcount, is a better fit for a fractional or interim engagement through Bolster.
Many firms default to a permanent search because the title sounds senior, when the actual near-term need is really a defined project with a clear endpoint and a natural stopping point once the submission clears agency review.
Step Three: Budget the Search Realistically
The gap between SHRM's two 2025 averages is worth sitting with: $5,475 to fill a typical nonexecutive role, climbing all the way to $35,879 once a search is executive-level and every agency fee and internal hour gets tallied1. A retained Hunt Club search for a permanent regulatory leader will track toward that higher figure, and the specialized nature of the role can push costs toward the top of that range given how thin the qualified talent pool often is.
Step Four: Plan for a Longer Timeline Than Usual
SHRM's 2025 data put the median time-to-fill for a nonexecutive role at 44 days from requisition to offer accepted, with executive roles often running longer, and a regulatory affairs search with a narrow qualification bar can extend well past that median2. If a client engagement's timeline depends on this hire, build in buffer rather than promising a date that assumes an average search, and communicate that buffer to the client early rather than discovering it together as a deadline approaches.
How do you verify a regulatory track record directly?
Ask candidates for specific, verifiable examples of submissions they led, including the therapeutic area and the regulatory pathway involved, and confirm those details with named references rather than accepting a general resume summary. A candidate whose regulatory experience is described only in broad terms is a real risk sign for a role this specialized.
Go one step further and ask what feedback the agency gave on that submission, positive or negative. A candidate who can speak honestly about a rejected or delayed submission usually understands the process better than one who only describes clean approvals.
Step Six: Plan the First Client Introduction
Whoever fills this seat will likely need to establish credibility with client scientific and regulatory teams quickly, especially on an active engagement. Plan a structured introduction for the new hire's first weeks, including which client relationships they'll take over first, rather than letting that handoff happen informally.
Step Seven: Decide How the Hire Represents the Firm at Agency Meetings
A regulatory leader will likely attend meetings with agency reviewers on behalf of client programs, and it's worth clarifying early how much independent authority they have to make representations in those settings versus when a principal or client sponsor needs to be present. This matters more for a permanent Hunt Club hire who will represent the firm indefinitely than for a narrowly scoped Bolster engagement tied to one submission.
Put this expectation in writing before the first agency meeting happens, not after a miscommunication creates a problem with a regulator or a client relationship the firm has spent years building.
In short, run the search in this order:
- Decide whether scientific credibility or hands-on regulatory submission experience matters more for this seat right now.
- Match the engagement to the need: a permanent leader through Hunt Club, or a fractional leader for one submission or a practice buildout.
- Plan for a longer timeline than usual, since a narrow qualification bar can stretch a regulatory search well past the median.
- Verify submissions with named references, including the therapeutic area and regulatory pathway of each example.
- Plan the first client introductions and agree how much independent authority the leader has in agency meetings.
What Good Looks Like
A life sciences consulting firm can name whether an open regulatory leadership seat prioritizes scientific credibility or submission execution, has verified a finalist's track record with named references, and has planned client introductions for the new hire's first weeks.
Building The Capability (5-Stage Skill Ladder)
How to Get Started
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A consultancy expanding into new states as it adds regulatory staff should confirm entity filings and registered agent coverage there stay current.
Project-based client billing across long regulatory engagements is easier to plan around with banking built for that uneven cash flow pattern.
Frequently Asked Questions
Is it realistic to find one candidate strong in both science and regulatory strategy?
It happens, but it's rarer than firms expect, and it's worth being honest about which skill matters more for your specific need rather than holding out indefinitely for someone who's equally strong at both.
Can a fractional regulatory leader work on multiple client engagements at once?
It depends on scope and confidentiality requirements between clients; some engagements require exclusivity during active submissions. Clarify this explicitly in the engagement terms rather than assuming it works the same as a permanent hire.
How do we verify a candidate's regulatory submission experience?
Ask for specific examples, including therapeutic area and regulatory pathway, and confirm with named references who worked directly on those submissions. General claims without verifiable specifics are a real risk sign for a role this specialized.
Sources
Where we quote a benchmark, we show its source. Other figures in this guide are estimates or general guidance, so check them against your own numbers.
- Average cost-per-hire (SHRM 2025 Benchmarking). SHRM 2025 Benchmarking Reports press release, 2025.
- Median time-to-fill, requisition open to offer accepted (SHRM 2025). SHRM 2025 Recruiting Executives Benchmarking data brief (PDF), 2025.
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