Senior Regulatory Operations Specialist
Core
Build, manage, and validate electronic regulatory submissions (eCTD, NeeS, XML Product Monographs, SPLs) for clients in the life sciences industry.
Role type
Senior Regulatory Operations Specialist (IC)
Builds
eCTD submissions, NeeS submissions, and associated documentation for regulatory authorities
Domain
Life Sciences / Regulatory Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eCTD submission creation and validation, NeeS submission management, XML Product Monograph and SPL creation, Microsoft Word/Adobe Acrobat/Excel/PowerPoint proficiency, project management, client liaison, document formatting, quality assurance, IT troubleshooting, process documentation (SOPs), training delivery, time management, deadline adherence
Preferred skills
Advanced knowledge of Innomar eCTD software, understanding of Canadian and US submission types, regulatory affairs guidance knowledge, conflict resolution, independent problem solving
Technologies
eCTD submissions builder, validation software, electronic submissions viewer, ESG NextGen Portal, Microsoft Office suite, Adobe Acrobat
Responsibilities
Create and format e-compliant documents; manage submission files in company systems; troubleshoot and fix document/submission issues; coordinate shipments for physical submissions; enter time daily; assist in writing marketing materials; maintain regulatory knowledge for consulting advice; backup for coordinating work; manage and prioritize billable/unbillable work; delegate tasks for external QC; assist in creating/reviewing SOPs; train department members; publish and validate XML Product Monographs and SPLs; create ASCII datasets; mitigate IT issues; lead and complete PRCI projects
Seniority
Senior, hands-on IC
