MSD (Merck & Co.) is hiring for a Specialist, Regulatory Data Steward (XEVMPD / IDMP) in Hyderabad (HITEC City). This is a high-impact pharma regulatory data management job focused on EMA compliance, XEVMPD submissions, IDMP standards, and Veeva Vault RIM systems.
If you are searching for Regulatory Data Steward jobs in Hyderabad, XEVMPD IDMP jobs in India, or Veeva Vault RIM regulatory roles, this opportunity is highly relevant for experienced regulatory professionals.
About the Role โ Regulatory Data Steward (XEVMPD / IDMP)
The role focuses on ensuring regulatory data quality, governance, and compliance for global pharmaceutical submissions. You will work on EMA XEVMPD reporting, IDMP data standardization, and regulatory data enrichment activities.
This is a key position supporting global regulatory operations and product registration data integrity across systems like EVWEB and Veeva Vault RIM.
Key Responsibilities
As a Regulatory Data Steward (XEVMPD / IDMP), your responsibilities include:
- Manage and execute XEVMPD submissions for investigational and approved medicinal products
- Handle submissions via EVWEB and Veeva Vault RIM systems
- Ensure compliance with EMA Article 57 requirements
- Investigate and resolve EMA acknowledgment reports and data issues
- Perform regulatory data mapping, cleaning, and enrichment
- Support IDMP (ISO standards) data alignment and governance
- Maintain and improve data quality and regulatory datasets
- Collaborate with cross-functional regulatory and IT teams
- Support SOPs and documentation for regulatory processes
- Contribute to Power BI dashboards and data reporting initiatives
Required Qualifications
To apply for this Regulatory Data Steward job in Hyderabad, candidates must have:
- Bachelorโs degree in Life Sciences, Pharmacy, IT, or related field
- Minimum 4 years of experience in Regulatory Affairs / Regulatory Operations
- Strong knowledge of:
- XEVMPD / EVPRM
- ISO IDMP standards
- SPOR data framework
- Regulatory Information Management (RIM systems)
- Experience with Veeva Vault RIM and EVWEB tools
- Understanding of SmPC and Module 3 (CTD) documentation
- Strong skills in data migration, mapping, and data quality management
- Experience working in global or matrix organizations
- Knowledge of Power BI, SharePoint, MS Excel, Power Automate (preferred)
Skills Required
- Regulatory data governance
- XEVMPD submission lifecycle management
- IDMP implementation knowledge
- Veeva Vault RIM expertise
- Analytical thinking and data accuracy focus
- Strong communication and stakeholder coordination
- Problem-solving in regulatory compliance environments
Benefits of This Job
Working with MSD as a Regulatory Data Steward offers:
- Global exposure in top pharmaceutical regulatory systems
- Opportunity to work on EMA-compliant data standards (XEVMPD & IDMP)
- Hybrid work model in Hyderabad
- Career growth in Regulatory Data Management and RIM domain
- Work with advanced tools like Veeva Vault RIM & Power BI
- Contribution to global patient safety and healthcare innovation
Salary Range (Estimated)
๐ฐ โน10 LPA โ โน22 LPA (Approx.)
Based on experience in Regulatory Affairs, XEVMPD, IDMP, and Veeva systems
How to Apply
