Director, Regulatory Data Standards & Governance

BioSpace; North Chicago (IL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus potential

Job summary

AbbVie is seeking a Director of Regulatory Affairs Data Standards and Governance to drive data standards adoption for regulatory submissions. This role collaborates with R&D, Supply Chain, Operations and Quality Assurance to ensure data quality and interoperability across the product lifecycle.

The ideal candidate will lead the Data Governance Office, implement enterprise data standards, and advocate for IDMP implementation globally.

Qualifications

• 6–8 years in regulatory affairs or related area.
• Knowledge of ISO IDMP requirements and EU IDMP implementation.
• Experience in a global matrix environment with diverse teams.

Responsibilities

• Lead data governance processes within Product Data Governance Office.
• Advance enterprise data governance and data interoperability for regulatory submissions.
• Define and implement data standards across AbbVie in collaboration with cross-functional teams.
• Advocate for ISO IDMP and related standards in industry forums.

Skills

Regulatory affairs

Data governance

Cross-functional collaboration

Technical communication

Education

Bachelor's degree in life sciences

Tools

COSMOS

RIM

Job description

AbbVie is seeking a Director of Regulatory Affairs Data Standards and Governance to drive data standards adoption for regulatory submissions. This role collaborates with R&D, Supply Chain, Operations and Quality Assurance to ensure data quality and interoperability across the product lifecycle.

The ideal candidate will lead the Data Governance Office, implement enterprise data standards, and advocate for IDMP implementation globally.