Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

29

Hyderabad, India
Hybrid
Xevmpd submission management
Idmp data governance
Veeva vault rim proficiency
This role ensures the quality of regulatory data within domains that directly influence patients using life-saving products

Job Summary

  • This role ensures the quality of regulatory data within domains that directly influence patients using life-saving products.
  • The specialist is responsible for managing and delivering XEVMPD submissions via EVWEB and Veeva Vault RIM to meet EMA compliance standards.
  • Candidates must possess a Bachelor's degree in a scientific or IT discipline along with at least four years of experience in Regulatory Affairs.

Matching Summary

This role ensures the quality of regulatory data within domains that directly influence patients using life-saving products.

Skills & Requirements

Must-have

  • XEVMPD submission management
  • IDMP data governance
  • Veeva Vault RIM proficiency
  • EMA regulatory framework knowledge
  • SmPC and Module 3 understanding
  • Data migration and enrichment

Nice-to-have

  • Power BI familiarity
  • Cross-functional collaboration skills
  • Methodical problem-solving approach
  • Autonomous work style
  • SPOR experience

Key Requirements

  • Bachelor's degree in science or IT
  • Minimum 4 years regulatory experience
  • Strong working knowledge of ISO IDMP
  • Proficiency with EVWEB and Veeva Vault RIM

Work Rights

Not specified

Tailored Resume

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