Regulatory Affairs Expert

Join a leading AI lab's cutting-edge GenAI team to be at the core of the AI revolution, where your expertise fuels the development of the most advanced Large Language Models.

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.

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.