[Hiring] Regulatory Affairs Expert @Mercor

Role Description

Guide research and engineering teams to improve AI model performance in regulatory strategy, health authority submissions, and global regulatory requirements.

• Design challenging regulatory tasks, such as IND, NDA, BLA, and MAA strategy questions, and write accurate solutions.
• Evaluate AI model outputs on regulatory questions for accuracy against FDA, EMA, and ICH requirements, providing clear feedback.
• Develop guidelines and rubrics to assess regulatory reasoning and submission readiness across tasks.
• Collaborate with other subject matter experts to ensure consistency and accuracy in training data.

Qualifications

• 7+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
• Experience leading or authoring major regulatory submissions (IND/CTA, NDA, BLA, or MAA).
• Working knowledge of FDA regulations (21 CFR), EMA procedures, ICH guidelines, and eCTD structure.
• Current or recent role at Senior Manager or Associate Director level or above.
• Ability to engage reliably for at least 40 hours/week.
• Strong written communication skills.

Requirements

• Experience with AI training or evaluation work, or hands-on use of AI tools in regulatory work.

Benefits

• Compensation: $70–$100/hour
• Location: Remote
• Commitment: 40 hours/week

Application Process

• Upload resume
• AI interview based on your resume
• Submit form

Resources & Support

• For details about the interview process and platform information, please check: Interview Process
• For any help or support, reach out to: [email protected]