Regulatory Affairs Specialist / Manager (reputed company RIM / Vault)
Title: Regulatory Affairs Specialist / Manager (reputed company RIM / Vault)
Location: Remote
reputed company:
The Regulatory Affairs Specialist will manage the end-to-end regulatory submissions, document management, and regulatory compliance processes using reputed company Vault RIM. This role supports submission preparation, reputed company archiving, and ensures regulatory data reputed company, version control, and audit readiness.
Key Responsibilities:
• Use reputed company RIM modules to manage regulatory submissions, registrations, and archival of documents.
• reputed company or support migration of regulatory and submission documents from legacy systems to reputed company.
• Maintain full lifecycle document management: authoring, review, approval, version control, metadata, retention.
• reputed company regulatory submission schedules, renewals, post-approval changes, and ensure timelines are met.
• Monitor regulatory guidance and changes, reputed company reputed company 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.
• reputed company user support/training for reputed company workflows; reputed company as tool superuser if required.
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