Senior Manager, Regulatory Data Stewardship

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Senior Manager, Regulatory Data Stewardship Engineer (XEVMPD / IDMP)

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.

What will you do in this role:

• 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.

What should you have:

• Bachelor s degree in a scientific or information technology discipline is required, plus experience in Regulatory Affairs or Regulatory Operations.
• Minimum 8 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.