Manager, Global Submission Management
Core
Own and drive the delivery of IND and global regulatory submissions, ensuring high-quality, compliant dossiers reach health authorities on time while operating as a connected global system.
Role type
Manager, Global Regulatory Submissions
Builds
Regulatory dossiers (IND and global applications) for innovative therapies
Domain
Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission strategy, cross-functional stakeholder alignment, eCTD publishing, risk tracking, timeline management, process improvement
Preferred skills
Experience with Veeva RIM, Lorenz docuBridge, global health authority interactions
Technologies
Veeva RIM, Lorenz docuBridge
Responsibilities
Lead cross-functional discussions to align submission strategy and timelines, coordinate IND or marketing application deliverables across global teams, manage eCTD submissions from planning through to delivery, track progress and identify risks to keep critical milestones on track, contribute to process improvements and innovation initiatives
Seniority
Manager, hands-on IC
