Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

Merck & Co., Inc.

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 XEVMPD submissions via EVWEB and Veeva Vault RIM to meet EMA Article 57 compliance.
  • Candidates must possess a Bachelor's degree in a scientific or IT discipline 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 compliance
  • Data migration and enrichment

Nice-to-have

  • Power BI visualization skills
  • SPOR knowledge
  • SmPC and Module 3 expertise
  • Cross-functional collaboration
  • Methodical problem-solving

Key Requirements

  • Bachelor's degree in science or IT
  • Minimum 4 years regulatory experience
  • Strong working knowledge of ISO IDMP standards

Work Rights

Not specified

Tailored Resume

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