Senior Specialist Regulatory Operations (Electronic Submissions)
Core
Manage end-to-end electronic publishing and submission of regulatory dossiers (eCTD/non-eCTD) for new and existing pharmaceutical products to meet agency requirements and deadlines.
Role type
Senior Specialist Regulatory Operations (Electronic Submissions)
Builds
Marketing Applications and maintenance submissions for global healthcare products
Domain
Healthcare / Regulatory Affairs / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eCTD requirements knowledge, regulatory dossier submission management, electronic transmission, quality control, document management systems, publishing software, global publishing processes
Preferred skills
MS Office, Adobe Acrobat Professional, registrations management systems, process improvement, mentoring
Technologies
eCTD Publishing software, Document Management Systems (DMS), MS Office, Adobe Acrobat Professional
Responsibilities
Publish, transmit, and archive Marketing Applications and maintenance submissions; Perform QC and technical validation of electronic submissions; Manage and monitor publishing schedules; Serve as Subject Matter Expert for publishing queries; Contribute to internal regulatory system guidelines; Mentor junior colleagues
Seniority
Senior, hands-on IC with leadership support
