Pharmaceutical CMC Regulatory Affairs Subject Matter Expert – AI Model Evaluation

🔥 10 hours ago

🇺🇸 United States – Remote

💵 $25 - $50 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🤖 Artificial Intelligence

Where this job comes from

Posted on Volga Partners's careers page, not through a job board

First seen by Remote Rocketship 10 hours ago

Still open on Volga Partners's site. Checked 3 hours ago.

Logo of Volga Partners

Volga Partners

1001 - 5000 employees

Founded 2020

🤖 Artificial Intelligence

🤝 B2B

🏢 Enterprise

Artificial Intelligence • B2B • Enterprise

Volga Partners is a technology services firm that specializes in Artificial Intelligence and Machine Learning solutions, data annotation and labeling, and development of customer service platforms powered by generative AI. The company also provides IT and software development services across web, app, full-stack, cybersecurity advisory, and e-commerce support, supported by a large multilingual crowd workforce and remote on-demand resources. Volga Partners focuses on partnering with enterprise clients to deliver scalable, cost-effective AI tooling, content moderation, linguistic services, and managed software projects.

📋 Description

• Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards • Review content related to quality systems, manufacturing, validation, submissions, development, and compliance activities • Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices • Identify unsupported claims, technical inaccuracies, missing context, and flawed reasoning • Validate information against FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices • Provide expert feedback, technically accurate corrections, and improvement recommendations • Apply project-specific evaluation criteria, scoring guidelines, and quality standards • Complete independent evaluations using designated online platforms within project timelines

🎯 Requirements

• Minimum of 4 years of professional experience in CMC Regulatory Affairs • Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Engineering, or related discipline • Experience supporting CMC regulatory submissions and lifecycle management activities • Strong knowledge of FDA regulations and ICH guidelines • Familiarity with global health authority requirements • Experience reviewing scientific and manufacturing documentation • Ability to critically evaluate technical and regulatory information • Strong analytical, research, and problem-solving skills • Excellent written English communication skills • Ability to work independently and follow detailed review instructions • Comfortable working within a task-based freelance engagement model

🏖️ Benefits

• Remote work from an eligible location • Flexible, variable, assignment-based schedule • Project-based work for supplemental income • Opportunity to contribute to advanced AI technologies • Experience contributing to AI evaluation initiatives • No AI background required

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