Regulatory Data Steward

Role Summary

The Regulatory Data Steward plays a key role in ensuring the quality, integrity, and compliance of regulatory data within the Company’s Regulatory Information Management (RIM) ecosystem. This role combines hands-on data analysis and remediation with governance execution, supporting both operational data quality oversight and strategic regulatory compliance needs. The successful candidate will leverage strong data analysis skills, expertise in regulatory data standards, and knowledge of regulatory processes to safeguard master and transactional data. This position provides the opportunity to work across multiple functions and systems, integrating internal and external data assets into RIM platforms, while ensuring alignment with international regulations and the Company’s data governance framework.

Responsibilities

1. Operational Data Stewardship:
   • Monitor, profile, and analyze regulatory data to ensure compliance with defined standards and design specifications (source-to-target validation).
   • Perform data quality analysis, error detection, documentation, and correction across diverse platforms (SQL, Excel, Informatica, Veeva Vault, third-party applications).
   • Investigate, troubleshoot, and document data issues raised by internal and external stakeholders.
   • Support root-cause analysis of data issues and recommend process and system improvements.
   • Ensure sensitive data is always protected through approved controls and practices.
2. Governance & Compliance:
   • Implement data governance policies, standards, and SOPs in partnership with Regulatory Data Owners.
   • Define and maintain data quality controls, metrics, and dashboards within data catalogs and reporting tools.
   • Ensure processes, methodologies, and metrics are consistently applied to maintain and improve data quality.
   • Identify and escalate regulatory and legal risks related to data issues, ensuring timely resolution.
   • Maintain awareness of evolving international regulatory requirements (e.g., IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/CMC, CTIS, ESMP) and assess their impact on RIM data.
3. Collaboration & Escalation:
   • Act as liaison between Data Owners, Business Process Owners, IT, and external vendors to ensure alignment on remediation and quality improvements.
   • Participate in cross-business unit forums to resolve data definition, production, and usage issues.
   • Communicate data quality concerns, escalations, and risks to stakeholders and governance forums in a clear and actionable manner.
   • Support knowledge sharing and mentoring across the data stewardship community.
4. Vendor & Process Oversight:
   • Establish, monitor, and report on Service Level Agreements (SLAs) with external vendors performing data stewardship and quality assurance activities.
   • Ensure external partners deliver consistent, compliant, and high-quality data services aligned with regulatory expectations.
5. Continuous Improvement:
   • Define processes and frequencies for metadata reconciliation and discrepancy resolution.
   • Recommend and implement new controls, process enhancements, and automation opportunities to improve data quality.
   • Support integration of new data assets from M&A, system migrations, or external regulatory sources into RIM.

Qualifications

• 5+ years of experience in the healthcare/pharmaceutical industry.
• 5+ years of experience in data management or data governance roles, ideally in a regulatory context.
• Bachelor‚Äôs degree in Life Sciences, Pharmacy, Data Science, Information Management, or a related field: required.
• Master‚Äôs degree in Regulatory Affairs, Data Management, or related discipline: preferred.
• Strong expertise with the Veeva RIM data model and regulatory metadata management.
• In-depth understanding of regulatory data standards (IDMP, SPOR, XEVMPD, eCTD, etc.).
• Strong analytical and problem-solving skills, including root-cause analysis and remediation.
• Hands-on experience with SQL, Excel, and reporting/visualization tools (Power BI, Tableau, or equivalent).
• Experience working in GxP environments and familiarity with data privacy regulations.
• Ability to work independently with minimal oversight, while influencing diverse stakeholders.
• Excellent communication skills, with the ability to translate technical data concepts into business terms.
• Experience with regulatory domains such as Labeling, CMC, and broader Regulatory Affairs processes.
• Exposure to public and hybrid cloud environments.

Skills

• Data governance
• Regulatory data standards
• Data quality management
• Stakeholder management
• SQL and data analysis
• Veeva RIM

Education

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, Data Science, Information Management, or related field
• Master‚Äôs degree in Regulatory Affairs, Data Management, or related discipline (preferred)