Full-Time
About Peer AI
We're a Bay Area-founded, remote-friendly company backed by investors with deep roots in both technology and life sciences. Our platform is live with top-tier pharma customers today, and we're growing fast in a $23B addressable market spanning document authoring, submission workflow management, and agency interactions with the FDA and EMA.
Our Vision
At Peer AI, we are working to clear the path for important scientific and medical discoveries, so that treatments reach the patients who need them as quickly as possible.
Our Values
Drive Impact: We focus on delivering real results for our users. Making their work easier, better, and more meaningful.
Be the Expert: We lead with deep expertise, curiosity, and honesty to guide others toward the best outcomes.
Go for Great: We take pride in pushing past good enough to deliver standout work in every detail.
Win as a Team: We succeed together. We build trust, share ownership, and help each other grow every day.
Do Right by Everyone: We honor the trust our customers, investors, and teammates place in us by choosing integrity, transparency, and long-term relationships over shortcuts and short-term gains.
The Opportunity
Our customers are regulatory affairs and medical writing teams at pharma, biotech, and CRO organizations. What they're buying from us is a platform their own writers use to produce documents that have to survive a health authority review. You're the person in the building who has been on the other side of that review.
You've owned submissions end to end. You've compiled a dossier, published it, filed it, and lived with what came back. That is the one thing we cannot hire around, and it's what this seat exists to bring inside.
Three things sit with you.
Product, where you translate how submissions genuinely work into logic our engineers can build.
Quality, where you review and improve what our agents produce against the standard a regulatory team would actually apply.
And Anticipate. Anticipate is our product for predicting the questions a health authority will raise on a submission, before the review clock starts. It's the pillar where your experience matters most, because the product is only as good as its understanding of what agencies actually ask and why.
You will shape the product, you QC the output, and you sit with customers' regulatory teams. As our platform moves further into the QC and publishing layer, there is scope for the seat to become operational.
You'll report to our Co-Founder and Chief Science & Regulatory Officer, and work day to day with our Regulatory & Medical Writing team, Engineering, Product, and our VP Sales.
What You'll Do
Ownership of the Product
Translate how submissions are actually assembled, published and filed into requirements an engineer can act on. Not "regulatory wants this," but the specific rule, the specific failure mode, and what good looks like.
Sit with engineers and product managers as a working colleague, not as a reviewer at the end of the cycle.
Define what the platform has to produce for a document to be submission-ready, and hold us to it.
Improve Anticipate
Bring the agency's point of view into Anticipate: what gets asked, on which modules, at which stage, and why.
Work with Product and Engineering to take Anticipate from beta to general availability.
Join customer conversations as the regulatory voice in the room. Our buyers are regulatory leaders, and they can tell within minutes whether the person across from them has filed anything.
Shape how we position and price Anticipate, based on what you hear in those rooms.
Own quality on AI-generated documents
Review, critique and improve agent-generated submission content: IND modules, clinical study reports, safety narratives, and lifecycle documents.
Score output against our measurement framework of accuracy, completeness, readability and consistency, then take failures back to the engineer who owns the agent as a reproducible case.
Be the person who says a document isn't ready, and can say exactly why.
Sit with customers
Work alongside customers' regulatory teams through pilots, first submissions and expansion.
Bring their submission standards, templates and validation expectations back into the product.
Support Sales on regulatory depth in evaluations, RFIs and technical diligence.
About You
You'll thrive in this role if you:
Have personally owned FDA regulatory submissions end to end inside a pharma or biotech sponsor: compiling, publishing and filing dossiers, not contributing a section to someone else's.
Have worked across INDs, NDAs or BLAs and lifecycle submissions, and can talk candidly about one that went wrong.
Have working fluency with the rulebook: FDA and EMA expectations, ICH and CTD structure, eCTD validation criteria, and submission quality standards.
Have familiarity with eCTD publishing and RIM systems, meaning you have operated them rather than watched someone else operate them.
Are genuinely comfortable reviewing, critiquing and improving AI-generated submission documents. Not tolerant of the idea. Comfortable doing it, repeatedly, and specific about where the output falls short.
Are credible in a commercial conversation with a regulatory leader, and willing to be in those conversations regularly.
Communicate with clarity, in writing above all. Most of this job is explaining something complicated, simply, to someone who doesn't have your context.
Work AI-first, using off-the-shelf and custom-built agents to accelerate your own work.
Thrive in ambiguity. There's no regulatory department here to absorb the unclear parts. There's you, and a small team of people who are very good at their own domains.
Bonus Points
You've worked at the intersection of regulatory content and software or AI tooling, in-house or with a vendor.
Experience with health authority interactions beyond the filing itself: information requests, meeting packages, and responses to agency questions.
Time at a Top 20 pharma, or at a biotech that took a product through approval.
You've been an early or design-partner user of a regulatory software product, and have views about what the vendor got wrong.
How We'll Set You Up
Your first weeks are spent inside real work before you own any of it: reading agent output against real submissions, sitting in on customer calls, and forming your own view of where the product falls short.
There's deep CMC writing experience here, and one of our co-founders came up through regulatory affairs and medical writing, so you won't be explaining the basics to anyone. You'd be the first here to have taken a filing all the way through. That's why this role exists
Anticipate has senior regulatory advisors attached to it, so you'll have experienced peers to test your thinking against.
Engineering is reachable. You'll bring reproducible cases directly to the engineer who owns the relevant agent, not to a queue.
Our platform is already in production across emerging biotechs, Top 20 pharma and global CROs, covering nonclinical, CMC and clinical documents. You're joining something live, not a prototype.
Work Environment & Travel
Location: Remote-first (US time zones), with quarterly offsites in San Francisco. Boston based strongly preferred.
Travel: ~25% for customer onsite visits, design partner sessions, and industry conferences.
Compensation & Benefits
Competitive base salary commensurate with experience
Meaningful equity grant in a high-growth, venture-backed company.
Comprehensive healthcare benefits.
How to Apply
Send your resume and a brief note to careers@getpeer.ai. We'd love to hear about a submission you owned end to end: what it was, what nearly went wrong, and what you did about it. Please use the subject line: Regulatory Submissions Specialist, [Your Name].
