- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Information Systems, or related discipline.
- 8+ years of experience in Regulatory Operations, Regulatory Data Management, Data Governance, or Regulatory Information Management.
- Strong understanding of
- Regulatory Information Management (RIM)
- Regulatory Data Governance
- IDMP
- Submission Data Management
- Metadata and Data Lineage
- Data Quality and Stewardship Practices
- Experience supporting global regulatory processes and data initiatives.
Preferred Qualifications
- Veeva RIM
- IDMP/SPOR
- Data Governance Platforms
- Regulatory Data Modeling
- Master Data Management
- Regulatory Analytics & Reporting
We are looking for an experienced Regulatory Data Consultant to drive regulatory data governance, standards management, and data quality initiatives across the regulatory landscape.
As a Regulatory Data consultant, you will be responsible for ensuring the quality, consistency, integrity, and governance of regulatory data across global regulatory operations. You will act as a key liaison between Regulatory Affairs, Data Governance, Business Process Owners, and Technology teams to establish and maintain trusted regulatory data assets and standards.
The ideal candidate combines deep regulatory domain expertise with experience in data governance, standards management, metadata, and regulatory information management.
Responsibilities
Regulatory Data Governance & Standards
- Maintain and govern regulatory data inventories, metadata repositories, and source-to-target mappings.
- Define and manage regulatory data standards, business rules, controlled vocabularies, and reference data.
- Develop and maintain a centralized Regulatory Standards Library aligned with enterprise and industry standards.
- Ensure consistent application and adoption of approved regulatory data standards across business functions.
- Collaborate with Data Governance Councils, Business Data Stewards, and Data Owners to evolve governance practices.
Data Stewardship & Quality Management
- Monitor regulatory data quality, completeness, consistency, and compliance metrics.
- Perform data profiling, issue identification, impact analysis, and remediation coordination.
- Support development and maintenance of data quality rules and controls.
- Drive root-cause analysis and corrective actions for data quality issues.
Regulatory Data Product Support
- Support regulatory data product development by identifying required entities, attributes, relationships, and standards.
- Maintain data lineage, traceability, and business definitions for critical regulatory data assets.
- Facilitate stewardship reviews and data health assessments.
- Coordinate resolution of data exceptions and governance-related issues.
Regulatory Operations Support
- Participate in requirements workshops and solution design discussions.
- Provide subject matter expertise on regulatory data standards and governance practices.
- Assess impacts of changing regulatory requirements on data models, standards, and processes.
- Support inspection readiness and compliance initiatives.
Stakeholder Collaboration
- Partner with Regulatory Affairs, Regulatory Operations, Data Governance, Master Data Management, Analytics, and IT teams.
- Provide regular updates on stewardship activities, risks, and compliance metrics.
- Drive alignment between business and technical stakeholders.
