Regulatory Affairs Consultant

Cmc Regulatory Affairs Consultant / Regulatory Affairs Strategy Consultants

Edison 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 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, 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.

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.

We're a fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it. We also offer full-time employees the following:

• 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
• Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability
• 12 weeks of paid parental leave for maternity, paternity, and adoption
• Pet care support with a yearly employer-funded stipend for your animal companions
• Commuter benefits so you can pay for transit and parking with pre-tax dollars
• 401(k) company matching
• $300 health and wellness benefit quarterly
• Lunch is on us every day you're in the office, and dinner is on us when you're working late
• Regular team off-sites and company events

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.