Associate Director, Regulatory Data Governance Lead
Location: Boston
Posted on: June 23, 2025
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Job Description:
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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.
Locations Boston, MA Worker Type Employee Worker Sub-Type Regular
Time Type Full time
Keywords: , Attleboro , Associate Director, Regulatory Data Governance Lead, IT / Software / Systems , Boston, Massachusetts
