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. Key Duties and Responsibilities 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. Knowledge and Skills 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. Education and Experience 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. Pay Range $163,200 - $244,800 #J-18808-Ljbffr Scorpion Therapeutics