Remote Regulatory CMC SME — AI Content Evaluator

Volga Partners; United States; Teletrabalho; USD 28 000 - 69 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Remote work

Project-based engagements

Freelance compensation

Resumo da oferta

Volga Partners seeks experienced Regulatory Affairs professionals to evaluate AI-generated regulatory content for accuracy and clarity. This role emphasizes technical review over filing submissions.

As a freelance, project-based SME, you will assess CTD/eCTD content, Module 3, and supporting documentation, providing expert feedback to improve AI model performance.

Remote work from the United States is possible; assignments are intermittent and compensation is hourly.

Qualificações

• 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.

Responsabilidades

• Evaluate AI-generated pharmaceutical content: assess accuracy, completeness, consistency, and regulatory compliance
• Review regulatory documentation: CTD/eCTD, Module 3, manufacturing, analytical data, validation summaries, stability reports
• Analyze technical reasoning: ensure conclusions are supported by evidence and regulatory expectations
• Identify errors and inconsistencies: detect unsupported claims, technical inaccuracies, deficiencies
• Validate information: reference FDA requirements, ICH guidelines, CTD standards, best practices
• Provide expert feedback: explain findings and recommend corrections
• Support AI quality improvement: apply evaluation criteria and quality standards
• Complete independent evaluations: use online platforms and meet timelines

Conhecimentos

Regulatory writing

CMC documentation

Regulatory affairs

Pharmaceutical submissions

Technical writing

English proficiency

Independent work

Formação académica

Bachelor’s degree or higher in Pharmacy/Pharmaceutical Sciences

Descrição da oferta de emprego

Volga Partners seeks experienced Regulatory Affairs professionals to evaluate AI-generated regulatory content for accuracy and clarity. This role emphasizes technical review over filing submissions.

As a freelance, project-based SME, you will assess CTD/eCTD content, Module 3, and supporting documentation, providing expert feedback to improve AI model performance.

Remote work from the United States is possible; assignments are intermittent and compensation is hourly.