About usEdison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.The OpportunityWe 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, but is ad-hoc in nature.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.Qualifications10+ 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 basedFlexible hours / flexible time zoneNote: For consulting opportunities, we do not offer benefits.

Regulatory Affairs Consultant (CMC) - Strategy Consultant

Emma

Responsibilities

Skills wanted:

Language(s) required:

Andrei Santalo

Andrew White

Samuel Rodriques

Andrei Santalo

Andrew White

Samuel Rodriques

About Edison Scientific:

edisonscientific.com/

Admin access needed