Regulatory Affairs

This role focuses on preparing, compiling, and publishing high-quality eCTD sequences for ANDAs, NDAs, and supplements in alignment with USFDA and ICH guidelines. The position requires managing Module 1 requirements, ensuring accuracy across Modules 2 and 3, and executing precise PDF publishing standards. The role involves coordinating with cross-functional teams to secure submission-ready documents and managing the end-to-end submission lifecycle through the FDA ESG system.