Strategic Director, Regulatory Data Standards & Governance

Allergan; Maidenhead; On-site; GBP 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k)

Job summary

AbbVie seeks a Director of Regulatory Affairs Data Standards and Governance to lead data governance for regulatory submissions and data interoperability across RIM, R&D, Supply Chain and Quality Assurance. The role sits within the Data Office and Enterprise Product Master Data initiatives.

Responsibilities include establishing enterprise data standards, advocating for ISO IDMP adoption, and collaborating with cross-functional teams to drive data quality and automation in COSMOS and related

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, medical technology pharmacology related life sciences.
• 6–8 years in regulatory affairs, R&D or related area.
• Knowledge of ISO IDMP requirements, EU IDMP implementation requirements and external organizations promoting regulatory data standards (e.g., ISO, WHO, FDA, EMA).
• Experience in a complex global matrix with diverse teams and strong communication skills.

Responsibilities

• Demonstrates leadership within the Product Data Governance Office and builds lean governance processes.
• Support enterprise-level data governance to improve data quality and interoperability for Regulatory and Supply Chain data.
• Define and implement data standards across AbbVie, aligning with external standards (EMA SPOR, FDA Data Standards Catalogue, WHO for ATC/INN, ICH).
• Act as an IDMP SME, advocating for AbbVie in industry forums and assessing regulatory system impact.
• Collaborate with EKS to build central Ontology services for Regulatory and Enterprise use.
• Roll out analysis tools to compare system dictionaries to enterprise standards and support data harmonisation.
• Assist COSMOS dictionary updates to reflect external standards and internal AbbVie standards.
• Contribute to training and change management for consistent data entry and reporting.

Skills

Data governance

Regulatory affairs

ISO IDMP

Data standards

Cross-functional collaboration

Excellent communication

Education

Bachelor’s degree in pharmacy, biology, chemistry, medical technology pharmacology related life sciences

Tools

COSMOS

Hubble

Data Catalogue

Job description

AbbVie seeks a Director of Regulatory Affairs Data Standards and Governance to lead data governance for regulatory submissions and data interoperability across RIM, R&D, Supply Chain and Quality Assurance. The role sits within the Data Office and Enterprise Product Master Data initiatives.

Responsibilities include establishing enterprise data standards, advocating for ISO IDMP adoption, and collaborating with cross-functional teams to drive data quality and automation in COSMOS and related