Job Description
Title: Regulatory Affairs Specialist / Manager (Veeva RIM / Vault)
Location: Remote
Role Overview:
The Regulatory Affairs Specialist will manage the end-to-end regulatory submissions, document management, and regulatory compliance processes using Veeva Vault RIM. This role supports submission preparation, dossier archiving, and ensures regulatory data integrity, version control, and audit readiness.
- Key Responsibilities:
- Use Veeva RIM modules to manage regulatory submissions, registrations, and archival of documents.
- Lead or support migration of regulatory and submission documents from legacy systems to Veeva.
- Maintain full lifecycle document management: authoring, review, approval, version control, metadata, retention.
- Track regulatory submission schedules, renewals, post-approval changes, and ensure timelines are met.
- Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams.
- Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities).
- Participate in audits/inspections; support documentation, SOPs, training.
- Provide user support/training for Veeva workflows; act as tool superuser if required.
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