Associate Director, Global Submission Management
$163,200–$244,800 year
HybridBoston, Massachusetts, United States
Job Summary
Oversee a portfolio of global regulatory submissions for development, lifecycle, and post-approval programs, focusing on Pulmonary or Cell & Gene Therapy. Develop submission plans, timelines, and tracking while ensuring consistent application of standards across planning through closeout. Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define scope, milestones, and deliverables. Coordinate cross-functional activities to ensure completeness, quality, and compliance, while identifying and resolving operational risks affecting timelines. Manage submission status updates, issue logs, and portfolio reporting, leading vendor functional service providers and driving continuous improvement within the team.
Required Qualifications
- Bachelor's degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline
- 7+ years of experience in regulatory submission management, regulatory operations, or regulatory/clinical project management
- Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions
- Experience working effectively in matrixed, cross-functional environments
- Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM
Desired Qualifications
- People-management experience preferred
- Experience managing submissions in Pulmonary or Cell & Gene Therapy is preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.