Regulatory Submission Specialist

Job overview

The Regulatory Submission Specialist role is remote-first, with Boston strongly preferred and quarterly San Francisco offsites; the posting also states about 25% travel. Compensation is a $150,000–$170,000 annual base salary plus equity. The role supports an AI software platform for pharma and biotech regulatory teams. The specialist brings end-to-end filing experience into product development and quality standards, helping translate submission practices into engineering requirements and assess AI-generated regulatory documents. The role also contributes regulatory expertise to a question-prediction product and customer engagements.

What you'll do

• Translate submission assembly, publishing, and filing practices into requirements for engineers
• define submission-ready document standards
• bring agency perspective to the question-prediction product and help move it from beta to general availability
• review and improve agent-generated content
• provide reproducible failure cases to engineers
• join customer conversations
• support Sales in evaluations, RFIs, and diligence and help shape product positioning and pricing.

What we're looking for

Skills & competencies

regulatory submission specialist

regulatory affairs

fda submissions

ind

nda

bla

ectd

rim systems

ai regulatory software

remote-first

boston preferred

$150k–$170k base

equity

about 25% travel

Work arrangement

• Weekend coverage required

Benefits & perks

• Equity, comprehensive healthcare, remote-first work, quarterly San Francisco offsites, and a structured ramp into live work and customer calls.

Why this role

Remote-first arrangement with Boston strongly preferred, quarterly San Francisco offsites, and about 25% travel. Requires end-to-end FDA submission ownership, experience across INDs, NDAs or BLAs and lifecycle submissions, fluency in FDA and EMA expectations, ICH/CTD structure and eCTD validation, and hands-on eCTD publishing and RIM systems experience.

About the employer

Strategic Employment is hiring for this role. Industry: Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services. Sector: 51.