Regulatory Affairs Expert (Pharmaceuticals)

Location: Remote, U.S. only; flexible hours and time zone.

Compensation: $200–$400 per hour.

Company

Builds and deploys AI scientist agents to accelerate scientific research and the development of new medicines.

What you will do

• Share day-to-day expertise from regulatory affairs and pharmaceutical data workflows.
• Describe regulatory tasks and problems where AI could provide value.
• Identify internal pharmaceutical systems used in standard workflows.
• Generate or review reference ground-truth artifacts, including reports, data files, and modules.
• Identify realistic sources of variance or corruption in study data.
• Identify and correct discrepancies in data quality.

Requirements

• 10+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, ideally with a sponsor.
• Bachelor's degree required; advanced degree preferred.
• Strong understanding of regulatory requirements, ICH guidelines, and FDA/EMA expectations.
• Experience supporting regulatory submissions for IND filings.
• Familiarity with later-phase and commercial submissions such as NDA/BLA and MAA is a plus.
• Must be based in the United States.

Culture & Benefits

• Part-time, ad-hoc consulting engagement of approximately 5–20 hours per week.
• Remote work with flexible hours and time zone.
• No benefits are offered for consulting opportunities.
• Mission-driven environment focused on AI, science, and medicine.