Associate Director, Regulatory Data Governance Lead

Role Summary

The Regulatory Data Governance Lead aligns Regulatory information and data standards with Takeda’s strategic business requirements, including Master Data Management, Regulatory strategy, industry standards, and Health Authority expectations. The role supports governance and data quality initiatives and coordinates Mergers & Acquisitions data integration within Takeda’s Regulatory Information Management ecosystem. The candidate should be collaborative, analytical, and experienced in metadata and data catalog management, capable of integrating diverse data assets, monitoring data quality, and promoting data stewardship, governance, and compliance.

Responsibilities

• 1. M&A Integration and Regulatory Data Transfer:
  • Coordinate assessment, transfer, and integration of Regulatory data during M&A activities, ensuring compliance with data governance standards.
  • Support due diligence by reviewing acquired data sources, data models, and ownership structures to identify alignment needs and integration risks.
  • Define and maintain data mapping and migration specifications for RIM and eDMS systems.
  • Oversee data remediation, migration validation, and quality control activities.
  • Liaise with DD&T, GRO, and cross-functional M&A integration teams to ensure consistent data ingestion and quality assurance across systems.
  • Track data-related risks, issues, and lessons learned throughout acquisition integration projects.
• 2. Regulatory Data Governance and Quality Management:
  • Oversee establishment and continuous improvement of Regulatory data governance policies and procedures.
  • Identify and assign data standard roles across the Regulatory data domain.
  • Maintain and evolve the Regulatory Data Catalog with proper data classification, lineage documentation, and quality rules.
  • Define and monitor metrics to measure data and metadata quality, usability, and compliance with standards.
  • Lead or support metadata management activities, including sensitive data tagging, business rule documentation, and data discoverability.
• 3. Change and Stakeholder Management:
  • Drive adoption of metadata and data governance practices through training and communication across stakeholders.
  • Participate in data governance and M&A forums to align priorities, report progress, and share best practices.
  • Support Regulatory Intelligence and Change Management assessments to evaluate regulatory impact on data governance.
  • Contribute to the definition of the RIM data roadmap, architecture diagrams, and interface specifications.

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Information Management, or related field; advanced degree preferred.
• 8+ years of experience in Regulatory Information Management, Regulatory Operations, or related pharmaceutical domain.
• Demonstrated experience in data integration, migration, or governance support within M&A or large-scale system transformations.
• Strong knowledge of Regulatory data models, RIM systems (Veeva Vault preferred), and Regulatory processes (Labeling, CMC, Registrations).
• Excellent analytical and problem-solving skills with attention to detail and compliance.
• Ability to coordinate across multiple stakeholder groups, balancing business and technical priorities.
• Experience in GxP environments and hybrid cloud solutions preferred.

Skills

• Data governance and metadata management
• Data mapping and migration
• Regulatory information management (RIM)
• Data quality management and stewardship
• Cross-functional collaboration and stakeholder management

Education

• Bachelor‚Äôs degree required; advanced degree preferred.

Additional Requirements

• Location: Massachusetts - Virtual