Regulatory Submissions Lead: FDA/EMA Expert

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

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.