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AI Regulatory Submission Automation Engineer

James Yamamoto

Full-time · Job · New_York

About the role

We're building the compliance layer that lets biotech teams file with the FDA and EMA without weeks of manual paperwork. Our platform already processes clinical trial signals and biomarker data for a dozen pharma partners, and now we need someone to close the loop between research findings and regulatory submission packages. You'll design pipelines that turn structured trial data into audit-ready submission documents, working closely with our regulatory affairs consultants to make sure every output holds up under FDA scrutiny. This is a high-stakes, high-trust role: the documents you help generate directly affect how fast life-saving therapies reach patients, and our clients expect nothing less than precision.

Responsibilities

  • Design automated pipelines that convert trial data into submission-ready documents
  • Partner with regulatory affairs consultants to validate document structure and content
  • Build audit trails that trace every generated statement back to source data
  • Maintain compliance with FDA and EMA formatting requirements
  • Monitor submission pipeline accuracy and flag discrepancies before filing

Requirements

  • 4+ years building data pipelines in a regulated industry
  • Experience with document generation or structured reporting systems
  • Familiarity with FDA/EMA submission formats a strong plus
  • Comfortable working directly with compliance and legal stakeholders
  • Strong Python skills and experience with cloud infrastructure

Benefits

  • Fully remote position with flexible hours
  • Health, dental, and vision coverage
  • Equity in a Series B biotech AI company
  • 20 days PTO plus company holidays
  • Annual learning and conference budget

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Categories

MLOps & AI Infrastructure Automation & AI Workflows

Skills

python langchain rag openai api aws

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Job Type

Full-time

Level

Senior

Language

English

Salary Range

$160k – $200k / year

AI Expertise

MLOps & AI Infrastructure Automation & AI Workflows

Skills

python langchain rag openai api aws docker

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