Associate Director, Global Submission Management

General Summary:

The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions for development‑stage, lifecycle, regional, and post‑approval, as well as supporting activities required to enable, maintain, and advance global product registrations. The disease area focus of this role will be Pulmonary or Cell & Gene Therapy.

This role ensures routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies and operational objectives. This role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support coordinated submission planning, execution consistency, and steady‑state portfolio throughput.

Key Duties and Responsibilities:

• Provides oversight for a defined portfolio of regulatory submissions, from planning through submission and closeout
• Develops and maintains submission plans, timelines, and tracking across multiple programs
• Ensures consistent application of submission management standards, tools, and processes
• Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables
• Coordinates cross‑functional activities to ensure submission completeness, quality, and compliance
• Identifies, manages, and resolves operational risks affecting submission timelines or quality
• Oversees preparation of submission status updates, issue logs, and portfolio‑level reporting
• Supports workload planning and capacity management across the submission portfolio
• Escalates risks appropriately when submissions approach higher‑impact or higher‑complexity thresholds
• Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs)
• Contributes to continuous improvement, knowledge sharing, and talent development within submission management
• Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI driven tools, and maintains a continuous learning mindset to strengthen GSM decision-making and operational efficiency
• Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.

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 skills
• Ability to drive execution consistency, compliance, and operational efficiency

Education and Experience:

• 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
• People‑management experience preferred
• Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM
• Experience managing submissions in Pulmonary or Cell & Gene Therapy is preferred

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