Regulatory CMC Submission Writer – AI Model Evaluation

Job not on LinkedIn

🔥 19 minutes ago

🇺🇸 United States – Remote

💵 $25 - $50 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

✏️ Content Writer

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This company has sponsored H1B visas in the past.

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Volga Partners

WebsiteLinkedInAll Job Openings

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 scientific, technical, and regulatory accuracy, completeness, consistency, and compliance • Review CTD/eCTD submissions, Module 3 documentation, manufacturing information, analytical data, validation summaries, and stability reports • Analyze whether AI-generated conclusions are supported by scientific evidence, regulatory expectations, and accepted documentation practices • Identify unsupported claims, technical inaccuracies, documentation deficiencies, missing context, and flawed regulatory reasoning • Reference FDA requirements, GMP regulations, ICH guidelines, CTD standards, and accepted pharmaceutical industry practices • Provide expert feedback, explain findings, and recommend technically accurate corrections • 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 Regulatory Writing, CMC Documentation, Regulatory Affairs, or Pharmaceutical Submission Support • Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Regulatory Affairs, Life Sciences, Engineering, or a related discipline • Experience authoring, reviewing, or supporting pharmaceutical regulatory submissions • Experience preparing CTD and/or eCTD documentation • Familiarity with Module 3 (CMC) documentation requirements • Knowledge of FDA regulations, CTD structure, and relevant ICH guidelines • Experience reviewing scientific, manufacturing, analytical, and stability documentation • Ability to critically evaluate scientific and regulatory information • Strong technical writing, editing, and document review skills • Strong analytical, research, and problem-solving abilities • Excellent written English communication skills • Ability to work independently and follow detailed review instructions • Must understand and be comfortable with a task-based freelance engagement model. • RAC certification • PharmD, MS, MBA, PhD, or other advanced scientific credentials • Experience supporting IND, NDA, BLA, ANDA, MAA, or equivalent submissions • Experience preparing or reviewing Module 2 and Module 3 documentation • Knowledge of electronic submissions and eCTD publishing processes • Experience compiling manufacturing, analytical, validation, and stability data • Global regulatory submission experience • Experience performing submission readiness assessments and document quality reviews • Experience collaborating with Regulatory Affairs, Quality, Manufacturing, Analytical Development, and Technical Operations teams • Familiarity with AI evaluation, data annotation, or quality review activities

🏖️ Benefits

• Remote work • Flexible, variable, assignment-based schedule • Project-based freelance 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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