Associate Director, Global Submission Management
Vertex Pharmaceuticals
August 20, 2026
Remote friendly (Boston, MA)
United States
Operations
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
- 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