Director, Regulatory Affairs Data Standards and Governance
AbbVie
August 22, 2026
Remote friendly (North Chicago, IL)
United States
$160,500 - $305,000 USD yearly
Corporate Functions
Director, Regulatory Affairs Data Standards and Governance
Responsibilities:
- Lead data governance processes in the Product Data Governance Office; build lean, effective governance.
- Support the Enterprise Product Master Data (EPMD) Data Office initiative to establish enterprise data governance, improve data quality/interoperability, and resolve Regulatory and Supply Chain data integration and change control challenges.
- Define and implement consistent data standards processes across AbbVie using external standards, including EMA (SPOR), FDA Data Standards Catalogue, WHO (ATC Codes and INN), and ICH.
- Use AbbVie’s Data Catalogue to define critical data elements, enable data lineage verification, and support interoperability across the product lifecycle.
- Act as an ISO IDMP SME; advocate in industry forums and assess impacts to AbbVie Regulatory systems/processes.
- Represent AbbVie in forums for cloud/structured submissions, eCTD4, structured content authoring, and regulatory industry standards; prepare for data-submission regulatory requirements.
- Collaborate with Enterprise Knowledge Services (EKS) to build central Ontology services using standards (ISO/WHO/ICH/Health Authorities).
- Support rollout, implementation, and training of ontology/analysis tools for harmonization, remediation, and synonym matching.
- Maintain COSMOS RIM system dictionaries/vocabularies aligned with enterprise standards to support submissions (including EU IDMP) and FHIR projects.
- Deliver COSMOS releases and enhance COSMOS/Hubble configuration to improve automation and data optimization; manage dictionary updates for standardized data entry and reporting.
Qualifications:
Required Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology, pharmacology) or related life sciences.
Required Experience:
- 6–8 years in regulatory affairs, R&D, or related area.
- Knowledge of ISO IDMP and EU IDMP implementation requirements and external regulatory data standards organizations (ISO/WHO/FDA/EMA).
- Experience in a complex global matrix environment.
- Strong oral and written communication.
Preferred Experience:
- Electronic regulatory submissions and data standards; regulatory affairs strategy experience.
- Large cross-functional master data governance projects.
- Advocacy in industry forums for IDMP/ePI and related technology.
- Interest in an SME role for Regulatory business applications and development.
Benefits:
- Paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Application instructions: Not specified in the provided text.
Responsibilities:
- Lead data governance processes in the Product Data Governance Office; build lean, effective governance.
- Support the Enterprise Product Master Data (EPMD) Data Office initiative to establish enterprise data governance, improve data quality/interoperability, and resolve Regulatory and Supply Chain data integration and change control challenges.
- Define and implement consistent data standards processes across AbbVie using external standards, including EMA (SPOR), FDA Data Standards Catalogue, WHO (ATC Codes and INN), and ICH.
- Use AbbVie’s Data Catalogue to define critical data elements, enable data lineage verification, and support interoperability across the product lifecycle.
- Act as an ISO IDMP SME; advocate in industry forums and assess impacts to AbbVie Regulatory systems/processes.
- Represent AbbVie in forums for cloud/structured submissions, eCTD4, structured content authoring, and regulatory industry standards; prepare for data-submission regulatory requirements.
- Collaborate with Enterprise Knowledge Services (EKS) to build central Ontology services using standards (ISO/WHO/ICH/Health Authorities).
- Support rollout, implementation, and training of ontology/analysis tools for harmonization, remediation, and synonym matching.
- Maintain COSMOS RIM system dictionaries/vocabularies aligned with enterprise standards to support submissions (including EU IDMP) and FHIR projects.
- Deliver COSMOS releases and enhance COSMOS/Hubble configuration to improve automation and data optimization; manage dictionary updates for standardized data entry and reporting.
Qualifications:
Required Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology, pharmacology) or related life sciences.
Required Experience:
- 6–8 years in regulatory affairs, R&D, or related area.
- Knowledge of ISO IDMP and EU IDMP implementation requirements and external regulatory data standards organizations (ISO/WHO/FDA/EMA).
- Experience in a complex global matrix environment.
- Strong oral and written communication.
Preferred Experience:
- Electronic regulatory submissions and data standards; regulatory affairs strategy experience.
- Large cross-functional master data governance projects.
- Advocacy in industry forums for IDMP/ePI and related technology.
- Interest in an SME role for Regulatory business applications and development.
Benefits:
- Paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Application instructions: Not specified in the provided text.