Regulatory Submission Specialist

Job Description

Job Description

About the Company
We're an early-stage, venture-backed AI company (Series A, backed by investors with deep roots in technology and life sciences) building software for pharma and biotech regulatory teams. Our platform helps regulatory affairs and medical writing groups produce the documents drug approvals depend on, work that has traditionally taken large teams weeks of manual effort. Our founders previously built and led a clinical research technology company, and we're already live with emerging biotechs, Top 20 pharma, and global CROs. We've chosen to grow off customer revenue rather than race to the next round, because we'd rather build something customers keep paying for.

About the Role
One of our co-founders came up through regulatory affairs and medical writing, and our team has deep CMC writing experience. What we don't have yet is someone who has taken a filing all the way through. That's the gap this seat fills. You'll bring the view from the other side of a health authority review to three areas. In product, you'll turn how submissions actually work into logic our engineers can build. In quality, you'll hold AI-generated output to a real regulatory standard. And in our newest product, which predicts the questions a health authority will raise before the review clock starts, you'll work alongside senior regulatory advisors. You'll report to our Co-Founder and Chief Science & Regulatory Officer. In your first year, success looks like that product reaching general availability and a submission-ready standard our whole platform is measured against. As we move further into QC and publishing, there's room for this seat to grow into something more operational.

Key Responsibilities

• Translate how submissions are assembled, published, and filed into specific requirements engineers can act on
• Define what makes a document submission-ready, and hold the platform to that standard
• Bring the agency's point of view into our question-prediction product and help take it from beta to general availability
• Review and improve agent-generated content, including IND modules, CSRs, safety narratives, and lifecycle documents
• Take failures directly to the engineer who owns the agent as reproducible cases
• Join customer conversations as the regulatory voice in the room through pilots, first submissions, and expansion
• Support Sales on regulatory depth in evaluations, RFIs, and diligence, and help shape how we position and price our question-prediction product

Qualifications

• End-to-end ownership of FDA submissions at a pharma or biotech sponsor, whether you ran the filing yourself or led the team that compiled, published, and filed it
• Experience across INDs, NDAs or BLAs, and lifecycle submissions
• Working fluency in FDA and EMA expectations, ICH/CTD structure, and eCTD validation criteria
• Hands-on experience operating eCTD publishing and RIM systems
• Comfort critiquing AI-generated documents and being specific about where they fall short
• Credibility in commercial conversations with regulatory leaders
• Strong written communication and active use of AI tools in your own work
• Health authority interaction experience, time at a Top 20 pharma or a biotech that reached approval, or regulatory software experience is a strong plus

What We Offer

• $150,000–$170,000 base salary, plus equity
• Comprehensive healthcare
• Remote-first, Boston strongly preferred, with quarterly San Francisco offsites and about 25% travel
• A real ramp: your first weeks are spent inside live work, reading agent output against real submissions and sitting in on customer calls, before you own any of it
• Direct access to engineering, not a ticket queue
• The chance to help shorten the path from scientific discovery to approved treatments

Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.