Submission Senior Specialist
Core
Manages routine regulatory submissions to Health Authorities, ensuring quality documentation and eCTD compliance for global CMC submissions.
Role type
Senior regulatory submission specialist (CMC/eCTD)
Builds
Global CMC regulatory dossiers and eCTD submissions
Domain
Pharmaceutical regulatory affairs / CMC
Required skills
CMC/Quality dossier structure knowledge, eCTD compliance verification, submission tracking, document management, regulatory guidelines knowledge, electronic docbase management, content planning, cover letter/FDA form preparation, translation document management support, process improvement, attention to detail
Preferred skills
Science/technology degree background, experience with US export waivers, stakeholder coordination for document revisions
Technologies
Veeva Vault RIM, Lorenz Docubridge, Verity (Veeva Vault), Microsoft Office, eCTD viewers
Responsibilities
Track, collect, and review components for routine submissions; interact with responsible parties to ensure document quality; troubleshoot and coordinate revisions; build and manage dossier structures in Lorenz Docubridge; compile and publish eCTD submissions using Veeva Vault RIM; distribute and archive non-eCTD submissions; draft eCTD content plans; prepare Cover Letters, FDA Forms, and submission content plans; perform submission verification for eCTD compliance; maintain submission tracking data in Verity; lead contact for Literature References maintenance; assist with translation document management; support process and system improvement initiatives.
Seniority
Senior, hands-on IC