Strategic Project Management in Regulatory Affairs: A Framework for eCTD Submissions

Abstract

The Electronic Common Technical Document (eCTD) has become the global standard for regulatory submissions in the pharmaceutical and biotechnology industries. However, the process of compiling, validating, and submitting eCTD dossiers is complex, resource-intensive, and error-prone without effective project management. This review explores the integration of project management principles within regulatory affairs, focusing on eCTD-based submission workflows. By analyzing academic studies, industry case reports, and digital tools, we evaluate key project challenges, mitigation strategies, and performance metrics such as error rate, submission delays, and cross-functional collaboration. We further present block diagrams and a theoretical model of risk-based task prioritization. Future directions include AI-assisted planning, eCTD v4.0 harmonization, and regulatory PM certification. This review underscores that strategic project management is not merely supportive—but essential—for successful, compliant, and timely regulatory submissions.