Remote Pharma AI SME: Regulatory QA

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

Resumo da oferta

Volga Partners seeks experienced pharmaceutical professionals to evaluate AI-generated content for regulatory accuracy and scientific soundness. This project-based, remote role targets US industry experts with strong regulatory and quality backgrounds.

Pharmaceutical SMEs will assess regulatory, manufacturing, and compliance material, identifying errors and providing structured feedback to improve AI model performance. AI experience is a plus but not required.

Qualificações

• Minimum four years of relevant professional experience in the US regulated pharmaceutical or biotech industry.
• Strong knowledge of FDA requirements, GMP regulations, and ICH guidelines (ICH Q7–Q12).
• Ability to critically evaluate scientific, technical, and regulatory information.
• Excellent written English communication and independent work capability.
• Familiarity with AI model evaluation and structured reviews is a plus.

Responsabilidades

• Evaluate AI-generated pharmaceutical content for accuracy, completeness, and regulatory compliance.
• Review information related to quality systems, manufacturing, validation, submissions, and development.
• Analyze technical reasoning and determine if conclusions are supported by scientific principles and regulatory expectations.
• Identify errors, inconsistencies, and missing context in content.
• Provide expert feedback with precise corrections and improvement recommendations.
• Complete independent evaluations using designated online platforms on schedule.

Conhecimentos

CMC Regulatory Affairs

Pharmaceutical Quality Assurance

CMC Science / Technical Development

Regulatory CMC Submission Writing

Quality Control / Analytical Dev

GMP Compliance / Validation

Regulatory Compliance Auditing

Pharmaceutical Manufacturing / MSAT

Formação académica

Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs

Descrição da oferta de emprego

Volga Partners seeks experienced pharmaceutical professionals to evaluate AI-generated content for regulatory accuracy and scientific soundness. This project-based, remote role targets US industry experts with strong regulatory and quality backgrounds.

Pharmaceutical SMEs will assess regulatory, manufacturing, and compliance material, identifying errors and providing structured feedback to improve AI model performance. AI experience is a plus but not required.