Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

med-in.at

Hyderabad, , India
Hybrid
Xevmpd submissions management
Idmp data governance
Regulatory data quality assurance
Be part of a global healthcare biopharma company with a 130-year legacy focused on innovation and ethical integrity

Job Summary

  • Be part of a global healthcare biopharma company with a 130-year legacy focused on innovation and ethical integrity.
  • The Regulatory Data Steward ensures the quality and regulatory readiness of product registration data impacting life-saving medicines.
  • Join a digitally driven team that leverages data, analytics, and custom software to tackle major global health threats.

Matching Summary

Be part of a global healthcare biopharma company with a 130-year legacy focused on innovation and ethical integrity.

Skills & Requirements

Must-have

  • XEVMPD submissions management
  • IDMP data governance
  • Regulatory data quality assurance
  • EVWEB and Veeva Vault RIM proficiency
  • European Medicines Agency compliance
  • Data migration and enrichment

Nice-to-have

  • Power BI familiarity
  • Cross-functional project teamwork
  • Strong prioritization and problem-solving
  • Effective communication and collaboration
  • Autonomous and methodical work style

Key Requirements

  • Bachelor’s degree in scientific or IT discipline
  • Minimum 4 years regulatory affairs or operations experience
  • Strong knowledge of XEVMPD, IDMP, SPOR, and RIM systems
  • Understanding of European regulatory framework including SmPC and Module 3
  • Experience with EVWEB, Veeva Vault RIM, SharePoint, Microsoft 365 apps

Work Rights

Not specified

Tailored Resume

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