Job Details

Regulatory Data Governance Lead

The Regulatory Data Governance Lead will ensure regulatory information and data standards are aligned with Takeda's strategic business requirements including Master Data Management (MDM), Regulatory strategy, industry standards, and evolving Health Authority (HA) expectations.

In addition to supporting ongoing governance and data quality initiatives, this role will play a critical coordination role in Mergers & Acquisitions (M&A) activities, ensuring that data from acquired entities, products, and systems are properly assessed, migrated, and governed within Takeda's Regulatory Information Management (RIM) ecosystem.

The ideal candidate is a strong collaborator with an analytical mindset, experienced in metadata and data catalog management, and skilled at working across a highly federated organization. He/she will help integrate diverse data assets into Takeda's systems, monitor the quality of Regulatory master and transactional data, and champion best practices in data stewardship, governance, and compliance.

Responsibilities:

1. M&A Integration and Regulatory Data Transfer

• Coordinate the assessment, transfer, and integration of Regulatory data during M&A activities, ensuring compliance with Takeda's 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 the execution of 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 the establishment and continuous improvement of Regulatory data governance policies and operating procedures.
• Identify and assign data standard roles (Data Quality, Stewards, Owners) across the Regulatory data domain.
• Maintain and evolve the Regulatory Data Catalog, ensuring proper data classification, lineage documentation, and quality rules.
• Define and monitor metrics to measure data and metadata quality, usability, and compliance with internal and external standards.
• Lead or support activities related to metadata management, including sensitive data tagging, business rule documentation, and data discoverability.

3. Change and Stakeholder Management

• Drive adoption of metadata and data governance practices through effective training and communication across stakeholder groups.
• Participate in data governance and M&A forums to align on priorities, report progress, and share best practices.
• Support Regulatory Intelligence and Change Management assessments to evaluate the impact of new regulations or process changes on data governance.
• Contribute to the definition of RIM data roadmap, architecture diagrams, and interface specifications.

Required Qualifications:

• Bachelor's degree in Life Sciences, Information Management, or related field; advanced degree preferred.
• 8+ years of experience in Regulatory Information Management, Regulatory Operations, or a related discipline within the pharmaceutical industry.
• Demonstrated experience in data integration, migration, or governance support within M&A or large-scale system transformation initiatives.
• 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.
• Proven ability to coordinate across multiple stakeholder groups, balancing business and technical priorities.
• Experience working in GxP environments and hybrid cloud solutions preferred.

Massachusetts - Virtual

U.S. Base Salary Range: $153,600.00 - $241,340.00

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.