Director, Global Regulatory Data Standards & Governance

Regulatory Jobs; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie seeks a Director, Regulatory Affairs Data Standards and Governance to lead enterprise data governance for regulatory submissions and data interoperability across R&D, Supply Chain, Operations and Quality.

In this role you will shape data standards, manage the COSMOS and Ontology initiatives, ensure ISO IDMP alignment, and represent AbbVie in industry forums.

Bachelor's in life sciences required; 6–8 years in regulatory affairs; strong communication and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field.
• 6–8 years in regulatory affairs, R&D or related area.
• Experience with ISO IDMP, EU IDMP and external standards bodies (ISO, WHO, FDA, EMA).
• Experience with electronic regulatory submissions and data standards (preferred).

Responsibilities

• Lead data governance processes within the Product Data Governance Office.
• Drive enterprise-level data standards adoption and data quality improvements.
• Collaborate cross-functionally to implement regulatory data standards (ISO, WHO, ICH).
• Support COSMOS releases and Ontology initiatives for regulatory data.
• Represent AbbVie in industry forums to promote IDMP and regulatory data standards.

Skills

Leadership

Cross-functional collaboration

Communication

Education

Bachelor's degree in life sciences

Tools

COSMOS

Ontology services

RIM

Job description

AbbVie seeks a Director, Regulatory Affairs Data Standards and Governance to lead enterprise data governance for regulatory submissions and data interoperability across R&D, Supply Chain, Operations and Quality.

In this role you will shape data standards, manage the COSMOS and Ontology initiatives, ensure ISO IDMP alignment, and represent AbbVie in industry forums.

Bachelor's in life sciences required; 6–8 years in regulatory affairs; strong communication and cross-functional collaboration skills.