- Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables.
- Track submission progress, identify risks or dependencies, and drive submission activities to completion.
- Independently lead or coordinate standardized submissions such as DSURs and IBs.
- Maintain regulatory submission records, correspondence, commitments, and associated trackers.
- Support periodic QC reviews of study TMFs and resolve documentation gaps.
- Establish and maintain regulatory document templates, formatting standards, naming conventions, submission-ready requirements, and archival practices.
- Maintain organized, inspection-ready regulatory repositories and archives.
- Support or lead regulatory department budget management, including forecasts, invoices, and payment approvals.