Regulatory Submission Specialist

Strategic Employment Partners (SEP); Boston (MA); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote-first

Travel ~25%

Quarterly SF offsites

Job summary

Strategic Employment Partners (SEP) seeks a regulatory affairs professional to own FDA submissions end-to-end and guide AI-enabled publishing for pharma/biotech regulatory tasks. You will translate submission workflows into actionable engineering requirements and ensure QA of AI-generated outputs.

You’ll work with senior regulatory advisors on a new product predicting questions from health authorities, moving toward general availability, with remote-first work and Boston preference, plus travel.

Qualifications

• End-to-end ownership of FDA submissions to sponsor
• Experience across INDs, NDAs and BLAs and lifecycle submissions
• Familiarity with FDA/EMA expectations, ICH/CTD structure, and eCTD validation
• Hands-on use of eCTD publishing tools and RIM systems
• Ability to critique AI-generated documents with specificity
• Credibility in regulatory commercial discussions
• Strong written communication and use of AI tools in work
• Regulatory authority interaction experience a plus

Responsibilities

• Translate how submissions are assembled, published, and filed into concrete requirements engineers can act on
• Define document submission-ready criteria and enforce platform standards
• Incorporate agency insight into the question-prediction product and drive toward GA
• Review and improve agent-generated content like IND modules, CSRs, safety narratives
• Escalate failures to the engineer as reproducible cases
• Join customer conversations as regulatory voice during pilots and first submissions
• Support Sales with regulatory depth in evaluations, RFIs, and diligence

Skills

End-to-end FDA submissions ownership

IND/ NDA/ BLA experience

FDA/EMA and ICH/CTD knowledge

eCTD publishing

AI document evaluation

Regulatory leadership discussions

Written communication with AI tools

Regulatory sponsorship experience

Top pharma/biotech exposure

Tools

eCTD publishing systems

Job description

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

• 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.