Regulatory Affairs Specialist / Manager (Veeva RIM / Vault)
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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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.
Apply tot his job
Apply To this Job