Practical understanding of CMC regulatory documentation and CTD/eCTD Module 3, including 3.2.S – Drug Substance and/or 3.2.P – Drug Product, associated structured/tabular CMC information, manufacturing process descriptions, analytical methods, specifications, control strategies, stability information, process validation and characterization information. The consultant will bridge Regulatory CMC scientists/engineers, Quality, IT, AI/Data teams, and technology vendors, translating scientific and regulatory authoring processes into technology requirements and driving business-facing activities across the IT System Development Life Cycle (SDLC).