About
Edison Scientific builds and commercializes AI agents for science. Scientific discovery moves too slowly, and autonomous AI agents are how we intend to fix that. We're assembling a team of top researchers and engineers across AI and biology to build an AI scientist.

The Opportunity
We are seeking an experienced CMC Regulatory Affairs Consultant / Regulatory Affairs Strategy Consultants for a flexible, part-time engagement. You'll serve as the subject matter expert who defines the gold standard for regulatory content — ensuring our platform produces outputs that reflect current agency expectations, withstand regulatory scrutiny, and are ready for global submission.

This engagement is designed to fit around existing commitments, at approximately 5–20 hours per week.

We engage with domain experts to help design and build these tasks, and help us know what we don’t know. Day to day that might look like any or all of the following sorts of activities (and more):

• Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.

• Describing common tasks or problems where AI could be of value in your workflows.

• Identify + describe internal pharma systems that are commonly used for standard workflows.

• Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc.

• Identify + add realistic sources of variance or data corruption in study data.

• Identify and correct discrepancies in data quality.

Qualifications

• 10+ years of experience in Regulatory Affairs within the pharmaceutical/biotechnology industry, ideally with a sponsor.

• Bachelor's Degree required; Advanced degree preferred.

• Strong understanding of regulatory requirements and familiarity with ICH guidelines and FDA/EMA expectations.

• Experience supporting regulatory submissions for IND filings; familiarity with later-phase and commercial submissions (NDA/BLA, MAA) a plus.
  

Why join us?

• Remote/US based

• Flexible hours / flexible time zone

Note: For consulting opportunities, we do not offer benefits.

Why join us?

• Competitive salary and equity

• Full healthcare coverage — we pay 100% of premiums for you and your dependents

• Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot

• 401(k) company matching

• $300 health and wellness benefit

• Lunch is on us every day you're in the office, and dinner is on us when you're working late

• Regular team offsites and company events

• A fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it

Edison Scientific is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.