Introduction
A regulatory affairs offer from a 40-person biotech reads nothing like an offer from a company with a marketed product and a decade of cash flow behind it, even when the base salary numbers look similar on paper. The base-plus-bonus-plus-benefits framework most people use to compare job offers was built for stable employers, and it quietly fails when one of the offers on the table comes from a company that might not exist in its current form in eighteen months. Evaluating a startup regulatory affairs offer well means asking a different set of questions, most of which have nothing to do with the number in the offer letter.
Start With the Equity, Honestly
Most startup offers include stock options, and occasionally restricted stock units at later-stage private companies. The number of shares or the percentage ownership figure sounds impressive until you work through what it actually represents. Ask directly for the strike price, the current 409A valuation, the vesting schedule, and the fully diluted share count the percentage is based on. A grant that looks generous as a raw share count can be nearly meaningless if the strike price is close to the current valuation, if the company has a long way to go before any liquidity event, or if future funding rounds are likely to dilute your percentage significantly before there is ever a chance to realize value.
It is reasonable, and increasingly common, to ask a hiring manager or HR directly what percentage of fully diluted equity your offer represents, rather than accepting a raw option count without context. A company that resists giving you that context, or the current valuation, is giving you information too — usually that the equity is being used to make a modest cash offer look larger than it is. Treat equity as a real but highly uncertain part of compensation: worth factoring in, never worth counting as guaranteed value when you are deciding whether the offer supports your life today.
Assess the Runway Before You Assess the Role
The single most important piece of information about a startup regulatory offer is one most candidates never ask for directly: how many months of operating cash does the company have, and when does it expect to need its next raise. A company between financings, with a runway measured in single-digit months, is a fundamentally different bet than one that just closed a well-covered Series B. This is not a question that should feel awkward to ask — reasonable startups expect it from experienced hires, and a candid answer, or a candid "we can't disclose that specifically, but here's the general picture," tells you a lot about how the leadership team handles hard questions from the people they are trying to recruit.
Useful proxies when a direct number is not available: how recently did the company raise, and from which investors; is the round oversubscribed or was it a difficult raise; has the company had layoffs in the past year; and what is the regulatory milestone the current funding is meant to carry the company through — an IND filing, a pivotal readout, a first commercial approval. A regulatory hire brought on specifically to prepare an IND or BLA submission is being hired against a near-term value-creating milestone, which is a meaningfully different risk profile than a hire brought on for general infrastructure-building with no near-term catalyst funding the runway.
Vesting, Cliffs, and What Happens if You Leave or the Company Doesn't Make It
Standard startup option grants vest over four years with a one-year cliff, meaning nothing vests until you have been there a full year, after which vesting typically continues monthly or quarterly. Leave before the cliff, and you walk away with no equity value at all regardless of how strong your contribution was. Ask specifically about the post-termination exercise window — the amount of time you have to exercise vested options after leaving, historically often just 90 days, though a growing number of companies now offer extended windows of several years, which matters enormously if you leave before a liquidity event and would otherwise have to pay to exercise options in a private company with uncertain value.
It is also worth asking, plainly, what happens to unvested and vested equity in an acquisition, and whether the company has single-trigger or double-trigger acceleration provisions in the event of a change of control. None of this should be treated as a red flag to raise in your first conversation with a hiring manager, but it is entirely normal to ask a founder, CFO, or head of HR these questions once an offer is on the table, and a company with reasonable, employee-friendly terms will generally be glad to walk you through them.
Pipeline Risk Is Regulatory Risk
Every biotech regulatory role is, in part, a bet on the science working. A single-asset company running one program through one pivotal trial carries binary risk that a broader platform company or one with several programs at different stages does not. This matters for your own planning beyond the obvious point about job security: a regulatory strategy built around one shot on goal often means the job itself is heavily front-loaded around a single filing, and what happens to your role after that filing — whatever the outcome — is worth asking about directly rather than assuming.
Ask what the regulatory pathway and prior agency interactions have looked like so far. A company that has already had a productive Type B meeting or has clear alignment with FDA on its development plan is in a meaningfully different position than one still working out its basic regulatory strategy. If you are the first regulatory hire, you may be the person building that strategy from scratch, which is a different and often more interesting job than executing an established plan, but it also means more of the outcome depends on your own judgment with less institutional support behind you.
The Title Inflation Problem
Startup titles run ahead of scope more often than they run behind it. A "Director of Regulatory Affairs" at a 20-person company may be the only regulatory person on staff, doing work that would be split across an associate, a specialist, and a manager at a larger organization — writing submissions, managing the document system, tracking correspondence, and briefing the CEO on regulatory strategy, all at once. That can be an excellent, accelerated way to build broad experience, but it is not equivalent to a director role at a company with an established regulatory department, and treating it as a like-for-like title comparison when you negotiate your next move will set you up for a difficult conversation with a future employer about actual scope of responsibility.
Ask what the team looks like today and what the hiring plan is for the function over the next year. A standalone regulatory hire with a credible plan to build out a team underneath them is a genuinely strong opportunity. A standalone hire with no such plan means you should expect to remain the entire regulatory function indefinitely, which is fine to accept with eyes open, but is worth knowing going in.
Comparing the Full Package
Base salary at early-stage biotechs is often modestly below what a comparable role would pay at a large pharmaceutical company, with the gap meant to be closed by equity upside and, at some companies, a somewhat richer annual bonus target. Benefits can vary more than people expect — some well-funded startups offer benefits on par with big pharma, while cash-constrained ones trim retirement matching, parental leave generosity, or professional development budgets first, since those are easier to cut than salary. Ask about all of these explicitly rather than assuming parity with your current employer, and weigh the total package against your own tolerance for the runway and pipeline risk you have just assessed, not against the base salary number alone.
Negotiating When Cash Is the Constraint
Startups frequently have less flexibility on base salary than large companies, simply because every dollar of cash compensation is a direct draw on a runway measured in months. If the base offer is below what you need, it is often more productive to negotiate on equity percentage, a signing bonus (sometimes easier to approve as a one-time cash outlay than a higher permanent base), title and scope, or a defined compensation review tied to the next funding milestone, rather than pushing hard on base salary alone. Coming to that conversation having already done the equity and runway homework above makes you a more credible negotiating partner, because you can speak specifically to what you are being asked to accept in exchange for the cash gap.
A Short List of Questions Worth Asking Before You Sign
- What percentage of fully diluted equity does this grant represent, and what is the current 409A strike price?
- How many months of runway does the company have, and when do you expect to raise again?
- What regulatory milestone is this funding round meant to carry the company through?
- What has FDA (or the relevant agency) said so far about the development plan, if anything?
- What does the regulatory team look like today, and what is the hiring plan for the function over the next year?
- What is the post-termination exercise window on vested options, and are there acceleration provisions on a change of control?
Asking all of these in a single conversation can feel like a lot, but spreading them naturally across the interview process — some to the hiring manager, some to HR or the CFO once an offer is close — is normal practice for an experienced candidate evaluating an early-stage company, and it tends to earn respect rather than suspicion from a team that has fielded these questions before.
Conclusion
A startup regulatory affairs offer is not a smaller or simpler version of a big pharma offer — it is a different kind of bet, and it deserves a different evaluation process. Get specific on the equity math, ask directly about runway and pipeline stage, be honest with yourself about what an inflated title really means for your resume and your day-to-day scope, and compare the whole package rather than anchoring on base salary. Candidates who do this homework before accepting make better decisions and negotiate from a stronger position than those who evaluate a startup offer as if it were simply a smaller number from a more established company.