Director, Global Submission Management

Job Description

General Summary:

The 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 developmentstage lifecycle regional and postapproval as well as supporting activities required to enable maintain and advance global product registrations.

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 steadystate 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 crossfunctional 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 portfoliolevel reporting
• Supports workload planning and capacity management across the submission portfolio
• Escalates risks appropriately when submissions approach higherimpact or highercomplexity 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 problemsolving skills
• Effective stakeholder management and crossfunctional communication skills
• Ability to drive execution consistency compliance and operational efficiency

Education and Experience:

• Bachelors degree in Life Sciences Regulatory Affairs Project Management or a related discipline
• 10 years of relevant experience with demonstrated leadership across submission portfolios
• Experience managing routine regional and lifecycle regulatory submissions across multiple regions
• Experience working effectively in matrixed crossfunctional environments
• Peoplemanagement experience
• Experience using modern project management and regulatory submission tooling including MS Project Smartsheet and Veeva RIM

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at