Director of Regulatory Data Standards & Governance

AbbVie; Maidenhead; On-site; GBP 90,000 - 150,000; Full time

Job summary

AbbVie in the United Kingdom is seeking a Director of Regulatory Affairs Data Standards and Governance to drive data standards and governance, enabling Regulatory data to connect with data from R&D, Supply Chain, Operations and Quality Assurance.

The role focuses on ISO IDMP, external standards, data catalogues, and cross-functional data interoperability to support regulatory submissions and lifecycle processes.

Qualifications

• 6 to 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 working in a complex global matrix environment with diverse team members.
• Good communication, both oral and written.

Responsibilities

• Lead data governance and standards as part of Product Data Governance Office.
• Collaborate to implement enterprise-level data governance and data quality improvements across Regulatory and Supply Chain data.
• Define and implement data standards across AbbVie, mapping to external standards (ISO, WHO, ICH, EMA).

Skills

Regulatory data standards

Data governance

Cross-functional collaboration

Effective communication

Education

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

Tools

COSMOS

Hubble

Ontology

RIM

Job description

AbbVie in the United Kingdom is seeking a Director of Regulatory Affairs Data Standards and Governance to drive data standards and governance, enabling Regulatory data to connect with data from R&D, Supply Chain, Operations and Quality Assurance.

The role focuses on ISO IDMP, external standards, data catalogues, and cross-functional data interoperability to support regulatory submissions and lifecycle processes.