[Remote] Regulatory Data Steward

Note: The job is a remote job and is open to candidates in USA. Takeda is a company focused on ensuring the quality and compliance of regulatory data within its Regulatory Information Management ecosystem. The Regulatory Data Steward will be responsible for data analysis, governance execution, and collaboration across multiple functions to maintain data integrity and support regulatory compliance needs.

Responsibilities

• 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
• 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
• 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
• 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
• 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

Skills

• 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's degree in Life Sciences, Pharmacy, Data Science, Information Management, or a related field: required
• 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
• Master's degree in Regulatory Affairs, Data Management, or related discipline: preferred
• Experience supporting large-scale data remediation, migration, or M&A integration projects
• Experience working with outsourced data stewardship vendors or data service providers
• Knowledge of emerging regulatory frameworks (ePI, ESMP, PQ/CMC)
• Familiarity with data quality and governance tools (e.g., Informatica, Collibra, or equivalent)
• Change management or process improvement certification (e.g., Lean, Six Sigma, PROSCI)
• Proven ability to influence without authority and drive adoption of governance processes

Benefits

• Short-term and/ or long-term incentives
• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• Up to 120 hours of paid vacation

Company Overview

• Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs. It was founded in 1781, and is headquartered in Tokyo, Tokyo, JPN, with a workforce of 10001+ employees. Its website is http://www.takeda.com.

Company H1B Sponsorship

• Takeda has a track record of offering H1B sponsorships, with 34 in 2025, 40 in 2024, 39 in 2023, 34 in 2022, 44 in 2021, 18 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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