Senior Specialist, Regulatory Affairs Submission Management
Core
Manages medium to high impact regulatory submission projects, establishing content planners, timelines, and coordinating with publishing vendors to ensure timely delivery of high-quality dossiers for regulatory authorities.
Role type
Senior Specialist, Regulatory Affairs Submission Management
Builds
Regulatory submission dossiers and publishing deliverables for Development, Marketing, and post-marketing applications
Domain
Pharmaceutical / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission project management, submission publishing, content planning, quality review of published output, process improvement, team leadership, cross-functional coordination
Preferred skills
PMP certification, RAC certification, experience in complex matrix environments, experience in QA, R&D, Scientific affairs, or operations
Technologies
Publishing software, business process management tools
Responsibilities
Establish and maintain submission content planners and timelines, facilitate tactical submission team meetings, coordinate with offsite publishing vendors, perform detailed quality reviews of published output, contribute to development of business processes and standards, mentor less experienced staff
Seniority
Senior, hands-on IC with mentorship responsibilities