Senior Specialist, Submission Management
Core
End-to-end management of IND and global regulatory submissions to ensure compliant dossiers reach health authorities on time.
Role type
Senior Specialist, Submission Management
Builds
Regulatory dossiers (IND and global applications) for health authorities
Domain
Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, eCTD publishing, stakeholder coordination, risk tracking, timeline management, data reporting
Preferred skills
Veeva RIM, Lorenz docuBridge, global regulatory requirements, process improvement
Technologies
Veeva RIM, Lorenz docuBridge
Responsibilities
Lead coordination of submission activities across global teams, manage IND and marketing application submissions from planning to delivery, execute eCTD publishing activities, track progress and identify risks, maintain submission data and reporting, coordinate non-eCTD submissions with international teams
Seniority
Senior, hands-on IC
