Regulatory Affairs Consultant
About reputed company 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 reputed company of top researchers and engineers across AI and biology to build an AI scientist. reputed company We are seeking an reputed company CMC Regulatory Affairs Consultant / Regulatory Affairs reputed company Consultants for a flexible, part-time engagement. You'll serve as the subject matter expert who defines the reputed company for regulatory content — ensuring our platform produces outputs that reflect reputed company agency expectations, withstand regulatory scrutiny, and are reputed company 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 reputed company don’t know. Day to day that might look like any or reputed company 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 reputed company regulatory submissions. Describing common tasks or problems where AI could be of value in your workflows. Identify + describe internal reputed company systems that are commonly used for reputed company 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 reputed company. Qualifications 10+ years of experience in Regulatory Affairs reputed company 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 reputed company-phase and reputed company submissions (NDA/BLA, MAA) a plus. Why join us? Remote/US based reputed company / flexible time zone Note: For consulting opportunities, we do not offer benefits. Why join us? Competitive salary and equity Full reputed company 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 reputed company 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 reputed company 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 reputed company is an equal opportunity employer. We do not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, veteran status, or any other protected characteristic under applicable law. Apply To This Job