Associate Director, Regulatory Data Governance Lead

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Associate Director, Regulatory Data Governance Lead

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking an Associate Director, Regulatory Data Governance Lead with the following duties: Oversee the establishment of Regulatory Information Management data governance policies; Lead efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance with internal and regulatory policies; Establish the data management practice and process: Own, lead and manage all aspects of RIM/eDMS metadata management practice including capture and maintenance, lineage, sensitive data tagging and management, metadata standards and data discoverability; Maintain the Regulatory Data Catalog: Document Data classification and quality rules; Identify and assign data governance roles, such as data quality leads, stewards, and data owners, within the regulatory data domain to ensure the integrity, compliance, and oversight of data related to the drug development lifecycle, including regulatory submissions, labeling, and product tracking; Oversee Regulatory Document data classification rules, compliance/retention rules, and business rules and access policies; Define process, frequency, and responsibility for identification of metadata discrepancies and resolution; Ensure that the metadata framework captures all relevant metadata needed for regulatory needs as well as data management compliance; Drive adoption of metadata management practice through training and effective change management across stakeholder groups; Participate in data governance forums, communicating changes and addressing issues related to data management; Support Change Management and Regulatory Intelligence assessment processes to evaluate impact on Regulatory Data; Support definition of RIM data Roadmap, RIM Architecture diagrams, Interface Specifications; up to 10% domestic and international travel required; up to 100% remote work allowed.

REQUIREMENTS: Bachelor’s degree in Information Technology, Computer Science or related field plus 5 years of related experience. Prior experience must include: Establish and Oversee Comprehensive Data Management and Quality Practices- Develop and manage data practices for RIM/eDMS systems aligned with Pharmaceutical regulatory data standards, including GxP, ICH, xEVMPD, and IDMP. Oversee data lineage, sensitive data tagging, metadata standards, discoverability, and data catalogs to ensure compliance and data quality, supported by structured processes for identifying and resolving data discrepancies; Lead Project Management and Regulatory Platform Implementation - Drive project management and technology implementation for Pharmaceutical R&D Regulatory Information Management (RIM) platforms, adhering to SDLC lifecycles and regulatory GxP data standards to ensure seamless integration with compliance requirements; Conduct Change Management and Regulatory Assessments - Perform change management initiatives and regulatory intelligence assessments to evaluate the impact of regulatory updates on data, coordinating with regulatory teams (e.g., submission publishing, CMC, drug labeling, compliance, and IT) to achieve aligned and cohesive project delivery. Utilize Advanced Analytical Skills and SQL for Data Insights and Innovation - Leverage SQL expertise to lead complex data extraction and analytics projects, utilizing analytical and problem-solving abilities to generate insights, drive business innovation, and resolve regulatory data issues across functions.

Full time. $153,600.00- $263,300.00 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #      . EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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