Executive, Regulatory Operations (eCTD Publishing)

The Executive, Regulatory Operations (eCTD Publishing) role focuses on preparing, compiling, and publishing high-quality eCTD sequences for USFDA submissions in alignment with ICH and FDA guidelines. The position involves managing module-specific requirements, ensuring technical accuracy, and coordinating cross-functionally to deliver submission-ready documents. Key responsibilities include executing PDF publishing standards, managing sequence metadata, and addressing validation errors to maintain compliance and audit trails.