Director, Global Submission Management

## Director, Global Submission Management Apply locations:
Boston, MAtime type:
Full time posted on:
Posted Todayjob requisition :
REQ-29520
** 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 development‐stage, lifecycle, regional, and post‐approval, 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 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
* 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, cross‐functional environments
* People‐management experience
* Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM
** Pay Range:**$190,400 - $285,600
** Disclosure Statement:
** The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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