• Support regulatory operations and publishing activities, including internal coordination and vendor management, to achieve on-time delivery. • Coordinate, compile, format, and publish regulatory submissions (e.g., IND/CTA, NDA/MAA, variations, amendments) as needed, ensuring technical compliance with applicable authority requirements. • Manage quality control reviews of submission deliverables, ensure conformance with company standards, RIM metadata requirements, and regulatory guidelines. • Coordinate sequencing and gateway testing for electronic filings, resolve technical submission errors and regulatory agency technical requests. • Drive best practices in document lifecycle management, including version control, archival, and audit preparedness. • Help maintain and optimize regulatory operations infrastructure, including RIM, templates, and workflow SOPs and WIs. • Establish and maintain submission and regulatory correspondence trackers, dashboards, and metrics for organizational visibility and audit readiness. • Drive continuous improvement of regulatory operations processes for efficiency, consistency, and audit readiness. • Monitor updates to electronic submission standards and implement required changes to processes and tools. • Interface with Regulatory Affairs, Non-clinical, Clinical, CMC, Quality, and IT etc. to align operational requirements with content strategy and submission timelines. • Coordinate with internal and external stakeholders (e.g., contractors, publishing vendors) to deliver on operational objectives, quality, and timelines. • Support readiness for health authority inspections of submission practices and document repositories. • Assist training in regulatory operations systems, methodologies, requirements and best practices.