Regulatory Affairs Consultant

About the Role

We are seeking an experienced CMC Regulatory Affairs Consultant / Regulatory Affairs Strategy Consultant 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, and is ad-hoc in nature.

Responsibilities

• 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.
• Identifying and describing internal pharma systems that are commonly used for standard workflows.
• Generating or reviewing reference ground-truth artifacts to evaluate against — reports, data files, modules, etc.
• Identifying and adding realistic sources of variance or data corruption in study data.
• Identifying and correcting 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.

Benefits

For full-time employees, we offer:

• 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

Schedule

Remote/US based, flexible hours and time zone, approximately 5–20 hours per week.