Associate Director, Global Submission Management

Associate Director, Global Submission Management The Associate Director, Global Submission Management (GSM) oversees the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. The role focuses on Pulmonary or Cell & Gene Therapy disease areas and ensures routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies. Key Duties and Responsibilities Provide oversight for a defined portfolio of regulatory submissions, from planning through submission and closeout. Develop and maintain submission plans, timelines, and tracking across multiple programs. Ensure consistent application of submission management standards, tools, and processes. 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 submission completeness, quality, and compliance. Identify, manage, and resolve operational risks affecting submission timelines or quality. Oversee preparation of submission status updates, issue logs, and portfolio‑level reporting. Support workload planning and capacity management across the submission portfolio. Escalate risks appropriately when submissions approach higher‑impact or higher‑complexity thresholds. Lead, coach, and support submission management staff including vendor functional service providers (FSPs). Contribute to continuous improvement, knowledge sharing, and talent development within submission management. Demonstrate the ability to effectively adopt and leverage emerging technologies, including AI‑driven tools, and maintain a continuous learning mindset. Proactively stay updated 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 preferred. Compensation and Benefits Pay Range: $163,200 - $244,800. The role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Benefits include medical, dental, vision, paid time off, educational assistance, commuting subsidy, charitable donation matching, 401(k) and more. Work Location Hybrid‑Eligible: work remotely up to two days per week. On‑Site Eligible: work five days per week on‑site with ad hoc flexibility. Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants. Eligibility for reasonable accommodations for qualified individuals with known disabilities is available. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)