Regulatory Affairs Expert - Pharma

About the job

Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey.

Position: Regulatory Affairs Expert
Type: Contract
Compensation: $70–$100/hour
Location: Remote
Commitment: 40 hours/week

Role Responsibilities

• 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

Must-Have

• 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.

Preferred

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

Application Process (Takes 20–30 mins to complete)

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

Resources & Support

• For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome
• For any help or support, reach out to: support@mercor.com

PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.