Remote CMC Regulatory Expert for AI Content Quality

Volga Partners; United States; Remote; USD 28,000 - 69,000; Part time

Job summary

Volga Partners is seeking experienced CMC Regulatory Affairs professionals for a remote, project-based freelance role evaluating AI-generated pharmaceutical content. Your regulatory judgment and technical expertise help improve AI models without traditional submissions.

You will assess accuracy, compliance, and scientific reasoning, providing structured feedback grounded in FDA, GMP and ICH guidelines. This is a freelance, intermittent opportunity with flexible scheduling.

Qualifications

• Minimum of 4 years of professional experience in CMC Regulatory Affairs.
• Strong knowledge of FDA regulations and ICH guidelines.
• Experience supporting regulatory submissions and lifecycle activities is preferred.
• Excellent written English communication skills and ability to work independently.

Responsibilities

• Evaluate AI-generated pharmaceutical content for accuracy and regulatory compliance.
• Review scientific and manufacturing information related to quality systems, validation, and submissions.
• Analyze AI-generated regulatory reasoning against regulatory expectations and industry best practices.
• Identify errors, inconsistencies, and unsupported claims in content.
• Provide clear expert feedback with recommended corrections and improvements.
• Complete independent evaluations within project timelines using designated platforms.

Skills

Regulatory Affairs

CMC

FDA Regulations

ICH Guidelines

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Regulatory Affairs or related field

Job description

Volga Partners is seeking experienced CMC Regulatory Affairs professionals for a remote, project-based freelance role evaluating AI-generated pharmaceutical content. Your regulatory judgment and technical expertise help improve AI models without traditional submissions.

You will assess accuracy, compliance, and scientific reasoning, providing structured feedback grounded in FDA, GMP and ICH guidelines. This is a freelance, intermittent opportunity with flexible scheduling.