Details
Skills
Regulatory compliance, Quality Assurance, GCP/ICH guidelines, FDA/DEA regulations (21 CFR 210 & 211), TMF/ISF management, SAE documentation, SOP development, Validation and verification reports, CAPA, Internal/external audit, Root cause analysis (5 Whys, Ishikawa), Clinical operations, Data integrity, Oracle ERP, Monday.com, MS Office, Smartsheet, Project management, and Process improvement
About
Regulatory Affairs and Quality Assurance professional with extensive experience supporting clinical trials, maintaining audit ready documentation, and ensuring compliance with FDA, DEA, ICH-GCP, and ISO standards. Strong background in technical writing, data integrity, and cross-functional collaboration across clinical, quality, and laboratory environments. Proven ability to streamline processes, manage documentation systems, and support regulatory submissions.
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