Location: Hyderabad, Telangana, India (Hybrid – HITEC City)
Company: Merck & Co., Inc.
Job ID: R392480
Employment Type: Full-Time
Application Deadline: May 1, 2026
Experience Required: Minimum 4 years (Not suitable for freshers)
About the Company
Merck & Co., Inc. is a globally leading research-driven biopharmaceutical organization with a legacy of over 130 years. Known as MSD outside the United States and Canada, the company focuses on delivering innovative medicines, vaccines, and animal health solutions to address some of the world’s most challenging diseases. With a strong emphasis on digital transformation, data science, and global collaboration, the organization continues to redefine modern healthcare.
Role Overview
The Specialist – Regulatory Data Stewardship (XEVMPD / IDMP) plays a critical role in ensuring high-quality, compliant regulatory data management for global submissions. This position is responsible for governance, validation, and maintenance of regulatory data used for XEVMPD reporting to the European Medicines Agency and for IDMP-related activities.
This is a highly specialized regulatory operations role that directly contributes to regulatory compliance, data integrity, and successful product registration across global markets.
Key Responsibilities
Manage and execute XEVMPD submissions for investigational and authorized medicinal products using EVWEB and Veeva Vault RIM
Lead and coordinate IDMP and XEVMPD submission activities ensuring adherence to global regulatory standards and timelines
Review and resolve EMA acknowledgements, follow-up reports, and ensure Article 57 compliance
Perform regulatory data mapping, migration, enrichment, and data quality improvement activities
Maintain and monitor submission tracking, status reporting, and stakeholder communication
Collaborate with cross-functional teams including Regulatory Affairs, Data Management, and IT
Support development and alignment of SOPs and work instructions related to regulatory data processes
Contribute to data governance initiatives including data cataloguing, data marketplace, and quality frameworks
Ensure compliance with global regulatory requirements, including EMA standards and IDMP frameworks
Required Skills and Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or Information Technology
Minimum 4 years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Data Management
Strong working knowledge of XEVMPD, EVPRM, ISO IDMP, SPOR, and RIM systems
Hands-on experience with EVWEB and Veeva Vault RIM
Understanding of European regulatory frameworks including SmPC and Module 3 (CMC)
Experience in data mapping, migration, and data quality management initiatives
Familiarity with Microsoft 365 tools (Excel, SharePoint, Power Automate); Power BI is an added advantage
Strong analytical thinking, problem-solving ability, and attention to detail
Effective communication and collaboration skills in a global, matrix environment
Preferred Skills
Knowledge of SPOR data models and regulatory data governance frameworks
Experience in data visualization and analytics tools such as Power BI
Exposure to regulatory submission systems and structured content management
Work Environment and Culture
Hybrid work model based in Hyderabad Tech Center
Global collaboration with cross-functional and geographically distributed teams
Innovation-driven environment focused on data, analytics, and digital transformation
Strong emphasis on employee growth, inclusion, and professional development
Important Note for Applicants
This role requires prior hands-on experience in regulatory data management and global submission systems. Freshers are not eligible for this position. Candidates seeking entry-level roles in regulatory affairs or pharmacovigilance should explore junior positions such as Regulatory Associate or Drug Safety Associate roles before applying to specialist-level positions.
How to Apply
Apply directly through the company’s official careers portal. For more verified and high-quality global regulatory affairs and pharmacovigilance job opportunities, visit ThePharmaDaily.com.
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