Global Director, Regulatory Data Standards & Governance

AbbVie; North Chicago (IL); On-site; USD 160,500 - 305,000; Full time

Job summary

AbbVie seeks a Director to drive regulatory data standards and governance, ensuring data quality and interoperability across Regulatory, R&D, Supply Chain, and Quality Assurance. The role emphasizes ISO IDMP expertise and collaboration across global teams to enable compliant data submissions.

You will lead governance processes, contribute to Enterprise Product Master Data initiatives, and work with COSMOS and ontology services to unify regulatory data across the product lifecycle.

Qualifications

• Bachelor’s degree in life sciences.
• 6–8 years in regulatory affairs or related area.
• Knowledge of ISO IDMP requirements and EU IDMP.
• Experience in a complex global matrix environment.
• Strong communication, both oral and written.

Responsibilities

• Lead Data Governance processes within the Product Data Governance Office.
• Support enterprise-level data governance to improve data quality and interoperability.
• Define and implement data standards across AbbVie with cross-functional colleagues.
• Advice on external standards (EMA SPOR, FDA Data Standards Catalogue, WHO, ICH).
• Build and use the Data Catalogue to define data elements and mappings for regulatory data.
• Ensure COSMOS/RIM dictionaries align with enterprise standards and support regulatory data submissions.
• Collaborate with EKS to build central Ontology services for regulatory and enterprise use.

Skills

Data governance

Regulatory data standards

ISO IDMP

Cross-functional collaboration

Data catalog

Regulatory submissions

Project leadership

Education

Bachelor’s degree in life sciences

Tools

COSMOS system

Ontology services

Job description

AbbVie seeks a Director to drive regulatory data standards and governance, ensuring data quality and interoperability across Regulatory, R&D, Supply Chain, and Quality Assurance. The role emphasizes ISO IDMP expertise and collaboration across global teams to enable compliant data submissions.

You will lead governance processes, contribute to Enterprise Product Master Data initiatives, and work with COSMOS and ontology services to unify regulatory data across the product lifecycle.