Associate Director, Global Submission Management

General Summary

• The Associate Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs (development-stage, lifecycle, regional, and post-approval) to enable, maintain, and advance global product registrations.
• Disease area focus:
  Pulmonary or Cell & Gene Therapy.

• Oversee a defined portfolio of regulatory submissions from planning through submission and closeout.
• Develop and maintain submission plans, timelines, and tracking across multiple programs.
• Apply submission management standards, tools, and processes consistently.
• Partner with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables.
• Coordinate cross-functional activities to ensure completeness, quality, and compliance.
• Identify, manage, and resolve operational risks impacting timelines or quality.
• Oversee submission status updates, issue logs, and portfolio-level reporting.
• Support workload planning and capacity management.
• Escalate risks when thresholds are exceeded.
• Lead, coach, and support submission management staff and vendor functional service providers (FSPs).
• Contribute to continuous improvement, knowledge sharing, and talent development.
• Adopt emerging technologies (including AI-driven tools) and stay current on technology/AI/automation and regulatory changes.

• Strong knowledge of global regulatory submission requirements, processes, and timelines.
• Experience with submission and project management tools and systems.
• Ability to manage multiple concurrent submissions and competing priorities.
• Strong organizational, planning, and problem-solving skills.
• Effective stakeholder management and cross-functional communication.
• Ability to drive execution consistency, compliance, and operational efficiency.

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or related discipline.
• 7+ years of experience in regulatory submission management/operations or regulatory/clinical project management.
• Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions.
• Experience in matrixed, cross-functional environments.
• People-management experience preferred.
• Experience with MS Project, Smartsheet, and Veeva RIM.
• Experience in Pulmonary or Cell & Gene Therapy preferred.

• $163,200 - $244,800