About this role
Job title: Director, Global Submission Management
About the Role The Director, Global Submission Management (GSM) leads strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. The role manages submissions at development-stage, lifecycle, regional, and post-approval phases and collaborates to enable, maintain, and advance global product registrations in alignment with regulatory strategies.
What You'll Do
- Provide strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs.
- Manage submissions for development-stage, lifecycle, regional, and post-approval activities.
- Support activities required to enable, maintain, and advance global product registrations.
- Ensure routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies.
What We're Looking For
- Experience managing global regulatory submissions across development-stage, lifecycle, regional, and post-approval programs.
- Ability to translate global regulatory strategies into actionable submission plans and timelines.
- Strong cross-functional collaboration skills to enable, maintain, and advance product registrations.
- Knowledge of regulatory requirements and compliance standards.