Specialist, Regulatory Data Stewardship (XEVMPD / IDMP)

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Specialist, Regulatory Data Steward (XEVMPD / IDMP)

The Opportunity

• Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
• Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
• Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our companys’ IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.

Role overview

As a Regulatory Data Stewards, you will play a pivotal role ensuring the quality of our regulatory data within regulatory domains, which will directly influence patients who use our life-saving products. The Regulatory Data Steward is responsible for the governance, quality and regulatory readiness of product registration data used for XEVMPD reporting to the European Medicines Agency (EMA) and for IDMP-related data activities. The role validates, maintains and delivers XEVMPD messages (manual and system-assisted), maps and enriches internal regulatory data, resolves data quality issues, and supports submissions via EVWEB and related tools to ensure compliance with regulatory requirements. If you are passionate about regulatory data management and governance and want to make a significant impact, we encourage you to apply.

Primary: XEVMPD, IDMP, Regulatory data, Veeva

Secondary: SPOR, Data quality, data management, SmPC / Module 3 knowledge, PowerBI

Key responsibilities

• Manage and deliver XEVMPD submissions for Investigational Medicinal Products and Authorized Medicinal Products via EVWEB and/or Veeva Vault RIM.
• Coordinate, lead and/or manage XEVMPD and IDMP submission activities to ensure electronic submissions meet internal and external quality standards and deadlines.
• Review, investigate and remediate EMA 3rd acknowledgements and follow-up reports to achieve Article 57 compliance.
• Track and communicate submission status and progress to the Regulatory function and other stakeholders.
• Coordinate operational activities to maintain compliance with regulatory obligations related to XEVMPD and IDMP.
• Perform data migration, mapping, cleaning and enrichment activities for XEVMPD/IDMP datasets.
• Support the alignment of procedural documentation (SOPs, work instructions) related to XEVMPD and IDMP processes.
• Support the Regulatory Data team with registration data management, including data integration and data integrity/enrichment initiatives to ensure accurate, compliant regulatory data for reporting and business decision-making.
• Contribute to data catalogue, data marketplace and data quality projects and initiatives.
• Who you are / required experience and skills
• Bachelor’s degree in a scientific or information technology discipline is required, plus experience in Regulatory Affairs or Regulatory Operations.
• Minimum 4 years’ experience and strong working knowledge of industry regulatory standards and initiatives (e.g., XEVMPD/EVPRM, ISO IDMP, SPOR, RIM systems).
• Good understanding of the European regulatory framework, including the structure and content of the Summary of Product Characteristics (SmPC) and Module 3 (Chemistry, Manufacturing and Controls).
• Proven ability to collect, aggregate and map data across documents and systems; experience in data migration and enrichment projects.
• Experience working in cross-functional project teams and within a multifunctional/geographically distributed matrix organization.
• Technical: strong proficiency with EVWEB and Veeva Vault RIM, experience with SharePoint, Microsoft 365 apps (Excel, Power Automate), and familiarity with Power BI is advantageous.
• Soft skills: autonomous, well organized, methodical and adaptable; strong prioritization and practical problem-solving skills; effective communicator and collaborator.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

#HYDIT2025

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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Regular

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Hybrid

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Job Posting End Date:

05/1/2026

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