Krimish Shah

About Krimish Shah

As a Regulatory Data Governance Lead with over 19 years of experience, I specialize in orchestrating digital transformation initiatives across Regulatory Information Management (RIM) domains for global pharmaceutical and medical device companies. I bring a strategic blend of technical expertise and regulatory insight to deliver scalable, compliant, and data-driven solutions.My core strengths include leading cross-functional initiatives that span data strategy, solution design, and enterprise implementation—ensuring alignment with both regulatory requirements and business goals. I have deep experience in data analytics, including extraction, transformation, enrichment, visualization, and modeling, enabling actionable insights that support regulatory and operational excellence.I’m well-versed in GxP, FDA 21 CFR Part 11, and ICH compliance, with a proven track record in software validation and qualification. My domain expertise spans regulatory submissions and publishing, labeling and artwork change control, CMC change management, and regulatory content management.I’m passionate about building governance frameworks that elevate data quality, ensure compliance, and accelerate innovation. Whether collaborating with cross-functional teams or leading global initiatives, I focus on delivering measurable impact and long-term value.

Experience

1. Associate Director, Regulatory Data Governance Lead

   Takeda

   Sep 2023 — Present · West Chester, PA, US

   As the Regulatory Data Governance Lead at Takeda, I drive the strategic execution of data governance initiatives across Global Regulatory Affairs (GRA), ensuring regulatory data is accurate, compliant, and aligned with enterprise standards. My role bridges regulatory operations, data strategy, and enterprise governance to support Takeda’s mission of delivering life-transforming treatments.I lead the development and implementation of governance frameworks that define ownership, prioritization, and criticality of regulatory data elements. This includes establishing and auditing data policies, standards, and procedures, and facilitating cross-functional alignment through working groups and executive forums. My responsibilities span:Operationalizing Takeda’s Regulatory Data Governance Program, including policy creation, stakeholder engagement, and compliance monitoring.Maintaining the Regulatory Data Catalog, overseeing metadata management, lineage tracking, and sensitive data tagging across RIM and eDMS systems.Driving data quality initiatives, collaborating with stewards and quality leads to remediate issues and define business rules for critical data elements.Championing education and adoption, by developing training materials and leading awareness campaigns to embed a culture of data stewardship.Partnering with enterprise governance bodies, ensuring regulatory data aligns with broader data strategy and intelligence efforts.I also play a key role in migration and transformation projects, where I oversee testing protocols, lifecycle state validation, and impact assessments to ensure data integrity and regulatory readiness

Education

• Dharmsinh Desai University

  Bachelor of Engineering - BE, Information Technology

  2002

Skills

• Visual Studio
• Sql
• Asp.net
• Business Analysis
• Ado.net
• Javascript
• Uml
• Object-Oriented Programming (Oop)
• Ssrs
• Entity Framework
• Iis
• Ajax
• Wcf
• Asp.net Ajax
• Xml
• Bmc Remedy
• Software Project Management
• Agile Methodologies
• Microsoft Sql Server
• Linq
• Tfs
• Software Development Life Cycle (Sdlc)
• Web Services
• Project Management
• Software Development
• Asp
• .net Framework
• C#
• .net
• Testing
• Pl/Sql
• Databases
• Silverlight
• Release Management
• Requirements Analysis
• Xslt
• Vb.net
• Solution Architecture
• Regulatory Submissions
• Business Process Automation