Specialist, Regulatory Data Stewardship (xevmpd / Idmp)

539

Hyderabad, India
Hybrid
Xevmpd submission management
Idmp data governance experience
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 standards.
  • Join a global healthcare biopharma company with a 130-year legacy dedicated to inventing for life and advancing disease prevention.

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 experience
  • Veeva Vault RIM proficiency
  • EMA regulatory framework knowledge
  • SmPC and Module 3 understanding
  • Data migration and enrichment skills

Nice-to-have

  • Power BI familiarity
  • Cross-functional collaboration
  • Autonomous problem-solving
  • Methodical work approach
  • SharePoint and Power Automate usage

Key Requirements

  • Bachelor's degree in science or IT
  • Minimum 4 years Regulatory Affairs experience
  • Strong working knowledge of ISO IDMP and SPOR

Work Rights

Not specified

Tailored Resume

Cover Letter