Remote Pharma Regulatory Auditor SME for AI Content

Volga Partners; United States; Remote; USD 34,000 - 69,000; Full time

Benefits offered by this job

Remote work

Project-based freelance engagement

Job summary

Volga Partners is seeking experienced Regulatory Compliance Auditors to evaluate AI-generated pharmaceutical content. This is a remote, project-based freelance role based in the United States, with compensation of $25-$50 per hour depending on specialty and experience.

You will assess scientific, regulatory, and quality information, identify errors, and provide expert feedback aligned with FDA requirements, GMP, ICH guidelines, and industry best practices.

Qualifications

• Minimum of 4 years of professional experience in Regulatory Compliance, Quality Auditing, GMP Auditing, Supplier Quality, Quality Assurance, or related pharmaceutical functions.
• Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Life Sciences, Regulatory Affairs, or a related discipline.

Responsibilities

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.

Skills

Regulatory Compliance

Quality Auditing

GMP Auditing

Supplier Quality

Quality Assurance

Independent Review

Education

Bachelor's degree

Tools

Lead Auditor certification

Job description

Volga Partners is seeking experienced Regulatory Compliance Auditors to evaluate AI-generated pharmaceutical content. This is a remote, project-based freelance role based in the United States, with compensation of $25-$50 per hour depending on specialty and experience.

You will assess scientific, regulatory, and quality information, identify errors, and provide expert feedback aligned with FDA requirements, GMP, ICH guidelines, and industry best practices.