Regulatory Affairs Informatics Specialist – Catalytic Data Science
DocumentClassification
I built structured datasets based on Module 3 standards to train machine learning models for biologics compliance. I collaborated with product and QA teams to ensure regulatory data integrity in AI-supported systems. The process involved preparing regulatory documents as labeled data to support the development and fine-tuning of compliance-focused AI models.
• Organized and labeled regulatory documents in alignment with CMC requirements.
• Identified key features and attributes in Module 3 documents for ML input.
• Validated accuracy and quality of data annotation with subject matter experts.
• Supported AI-driven analytics for inspection-readiness initiatives.
I built structured datasets based on Module 3 standards to train machine learning models for biologics compliance. I collaborated with product and QA teams to ensure regulatory data integrity in AI-supported systems. The process involved preparing regulatory documents as labeled data to support the development and fine-tuning of compliance-focused AI models. • Organized and labeled regulatory documents in alignment with CMC requirements. • Identified key features and attributes in Module 3 documents for ML input. • Validated accuracy and quality of data annotation with subject matter experts. • Supported AI-driven analytics for inspection-readiness initiatives.
2025 - Present