Description

About Freyr

Freyr is a leading Regulatory Solutions and Services company supporting global Life Sciences organizations across Regulatory Affairs, Pharmacovigilance, Quality, and Compliance.

Job Title: RA Data Governance Specialist

Location: Canada Remote

Employment Type: Full-Time / Contract

Role Overview

Support Regulatory Affairs (RA) data governance, data quality, and data modelling activities, ensuring alignment with enterprise standards, regulatory requirements, and internal processes.

Key/Primary Responsibilities:

Governance and Stewardship:

  • Maintain RA data governance frameworks, including roles for data owners and stewards
  • Oversee tickets and workflows for reference and master data changes (organization, substance, medicinal product). Service Now (SNOW)
  • Support harmonization of Regulatory reference and Master data models with enterprise standards (e.g., medicinal product, device, packaging hierarchies).
  • Support IDMP-based modelling and alignment of data between RIM and Master Data management system
  • Participate in medicinal product governance meetings and expert community sessions.
  • Support enterprise-level modelling principles (conceptual, logical, physical) and metadata management against internal and external benchmarks
  • Perform routine data quality checks and generate metrics reports.
  • Coordinate with Data Stewards and functional Data Owners to resolve data quality issues.
  • Track and report on KPIs related to accuracy, consistency, and completeness.
  • Act as operational liaison for RA Data Governance activities with internal teams.
  • Support communication and training sessions on data governance processes and systems.
  • Provide operational input and resources for projects impacting RA data governance.
  • Assist in configuration and testing of data governance tools
  • Manage Jira boards for RA data initiatives, including backlog prioritization, epics, and user stories. Ensure traceability of requirements and validation results in Jira for compliance. Monitor backlog and escalate issues as necessary.
  • Support running and reporting on KPI’s
  • Analyze data quality trends, monitoring progress and report findings to leadership
  • Prepare compliance reports for regulatory requirements (e.g., IDMP, XEVMPD)
  • Automate routine reporting tasks to improve efficiency
  • Translate analytics into actionable insights for stakeholders
  • Benchmark internal metrics against industry standards
  • Gather feedback from users to continuously improve reporting tools and outputs
  • Maintain and update data governance documentation, data catalogue entries, and controlled vocabularies.
  • Execute codification of rules in Data Quality tools and monitor adherence.
  • Support centralized master and reference data management (MDM/RDM) processes.

Secondary Responsibilities

Data Modelling:

  • Support harmonization of Regulatory reference and Master data models with enterprise standards (e.g., medicinal product, device, packaging hierarchies).
  • Support IDMP-based modelling and alignment of data between RIM and Master Data management system
  • Participate in medicinal product governance meetings and expert community sessions.
  • Support enterprise-level modelling principles (conceptual, logical, physical) and metadata management against internal and external benchmarks

Data Quality Management:

  • Perform routine data quality checks and generate metrics reports.
  • Coordinate with Data Stewards and functional Data Owners to resolve data quality issues.
  • Track and report on KPIs related to accuracy, consistency, and completeness.
  • Interactions / Stakeholder Coordination
  • Act as operational liaison for RA Data Governance activities with internal teams.
  • Support communication and training sessions on data governance processes and systems.

Project & Project Management Support

Provide operational input and resources for projects impacting RA data governance.

Assist in configuration and testing of data governance tools

Manage Jira boards for RA data initiatives, including backlog prioritization, epics, and user stories. Ensure traceability of requirements and validation results in Jira for compliance. Monitor backlog and escalate issues as necessary.

Reporting and Analytics

  • Support running and reporting on KPI’s
  • Analyze data quality trends, monitoring progress and report findings to leadership
  • Prepare compliance reports for regulatory requirements (e.g., IDMP, XEVMPD)
  • Automate routine reporting tasks to improve efficiency
  • Translate analytics into actionable insights for stakeholders
  • Benchmark internal metrics against industry standards
  • Gather feedback from users to continuously improve reporting tools and outputs

Qualifications & Experience

Education: Bachelor’s degree in life sciences, data science, or related field.

Experience: 3–5 years in data governance, data quality, or regulatory data management.

Technical Skills

  • Experience with data management in pharmaceutical regulatory affairs.
  • Familiarity with regulatory requirements, structured data submissions, and compliance practices, including XEVMPD & IDMP
  • Familiarity with data management and data quality/governance tools like Reltio, Collibra and Ataccama
  • Familiarity with Veeva RIM, Service Now, Jira and SAP appreciated

Soft Skills

Strong communication, business writing, and project management skills.

Experience facilitating meetings with cross-functional teams

What We Offer

Competitive compensation, global exposure, and opportunity to work on cutting-edge regulatory data governance initiatives.

Why Join Freyr

Be part of a fast-growing organization driving innovation in Regulatory Affairs and Data Governance across global life sciences companies.