Regulatory Affairs Expert

1\. Overview

Join a leading AI lab's cutting-edge GenAI team and help build foundational AI models from the ground up. We're seeking talented Regulatory Affairs subject-matter experts (SMEs) from the pharmaceutical and biotech industry to bring deep regulatory strategy and submissions expertise and elevate the quality of our AI training data. This is a full-time commitment of 40 hours per week.

This is a W-2 employment position with Cincinnatus LLC, with the opportunity to be placed at a leading AI Lab as part of their extended workforce.

2\. Key Responsibilities

• Guide research and engineering teams to close knowledge gaps and improve AI model performance in regulatory strategy, health authority submissions, and global regulatory requirements.
• Design challenging, realistic regulatory tasks, such as IND, NDA, BLA and MAA strategy questions, health authority meeting scenarios and labeling problems, and write accurate, well-structured solutions.
• Evaluate AI model outputs on regulatory questions for accuracy against FDA, EMA and ICH requirements, and provide clear, written feedback.
• Develop guidelines and detailed rubrics to assess regulatory reasoning, correct use of guidance, and submission readiness across tasks.
• Collaborate with other subject matter experts to ensure consistency and accuracy in training data.

3\. Core Qualifications

• 7+ years of dedicated professional experience in Regulatory Affairs within the pharmaceutical or biotech industry at a recognized, top-tier organization (e.g., a top-25 pharmaceutical company such as Pfizer, Merck, Roche, Novartis, AstraZeneca, Johnson & Johnson, AbbVie, Eli Lilly, Bristol Myers Squibb, Sanofi or GSK; a major biotech such as Amgen, Gilead, Genentech, Regeneron, Vertex or Biogen; a leading CRO such as IQVIA, ICON, Parexel, Syneos Health, PPD/Thermo Fisher, Labcorp/Fortrea or Medpace; or a regulator such as the FDA or EMA).
• Track record of leading or authoring major regulatory submissions (IND/CTA, NDA, BLA or MAA) and representing the company in health authority interactions such as FDA Type A, B or C meetings or EMA Scientific Advice.
• Working knowledge of FDA regulations (21 CFR), EMA procedures, ICH guidelines and eCTD structure.
• Current or most recent role at Senior Manager or Associate Director level or above, with demonstrable career progression (e.g., Regulatory Affairs Manager → Senior Manager → Associate Director → Director).
• Ability to engage reliably for at least 40 hours/week during weekdays.
• Experience with AI training or evaluation work, or hands-on use of AI tools in regulatory work, is a plus.
• Strong written communication skills and the ability to explain complex regulatory decisions clearly.

About Cincinnatus LLC

Cincinnatus LLC is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for contingent and contract-based opportunities. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives.

Equal Employment Opportunity

Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic.

Where you can work

This role is 100% remote, for applicants located in United States.