Director, Regulatory Affairs Data Standards and Governance

Job Description

The Director, Regulatory Affairs Data Standards and Governance is responsible for driving awareness and implementation of data standards and associated best practices in systems to support Regulatory Requirements for data submissions and to enable Regulatory data to connect with data sourced from other functions including R&D Development, Supply Chain, Operations and Quality Assurance. This role has functional responsibilities within RIM, in addition to performing a key role within the cross-functional Enterprise Product Master Data (EPMD) Data Office initiative.

• Demonstrates leadership within the Product Data Governance Office, building and executing lean and effective Data Governance processes.
• Support the Product Data Office initiative to establish enterprise-level data governance, improve data quality and interoperability to resolve key business challenges including Regulatory and Supply Chain data integration and Change Control processes.
• Through Data Office engagement, works with cross-functional colleagues to define and implement consistent processes for data standards implementation across Abb Vie. Accomplished by building detailed knowledge of external standards applicable to Regulatory business processes and submissions including:
• EMA standards (published through the SPOR platform)
• FDA Data Standards Catalogue
• World Health Organization (WHO) for ATC Codes and INN
• International Conference on Harmonization (ICH)
• Builds and uses Abb Vies Data Catalogue to drive clear definitions for critical data elements, supporting data lineage verification and mapping properties across systems for interoperability of Regulatory data across the product lifecycle.
• Demonstrates detailed knowledge of ISO IDMP requirements, and how the ISO IDMP standard is being implemented by Health Authorities globally. As an IDMP SME, advocate for Abb Vies interest in industry forums and collaborates with RPI colleagues to share knowledge learned through industry engagement and assess the impact to Abb Vies Regulatory systems and processes.
• Ensure that Abb Vies interests are represented in external industry forums for cloud-based submissions, structured data submissions, eCTD4, structured content authoring and the implementation of Regulatory industry standards. Prepare Abb Vie for the implementation of regulatory requirements on data submission topics to ensure sustained compliance with Health Authority requirements.
• Collaborates with EKS (Enterprise Knowledge Services) to build Abb Vies central Ontology services for Regulatory and Enterprise use, incorporating external standards published by organizations including ISO, WHO, ICH and Health Authorities.
• Supports the rollout, implementation and training of analysis tools which aid comparison of Abb Vie system dictionary terms and data to enterprise standards maintained in the Ontology to support cross-system and cross-functional data harmonisation, remediation and synonym matching.
• Engages with and communicates on data enrichment and harmonisation projects linked to system interoperability projects thus driving overall awareness.
• Support consistent data entry within COSMOS RIM by monitoring and maintaining system dictionaries and vocabularies in alignment with enterprise standards to support data submissions, FHIR projects and, to prepare Abb Vie to meet Regulatory compliance e.g. EU IDMP.
• Work with RIM colleagues to deliver COSMOS system releases that drive further automation, functionality, and data optimization using new technologies. Collaborate with RIM colleagues to define enhancements and improvements to COSMOS and Hubble configuration and processes. Support communications and training rollout to ensure adoption of consistent processes and best practices to drive data quality improvements.
• Update COSMOS system dictionaries and vocabularies to accommodate external standards and define and implement internal, Abb Vie standards to support consistent data entry and reporting. Manage and monitor COSMOS dictionaries and vocabularies in alignment with Ontology values and drive automation to reduce the burden and risk of manual data entry.

Required

Education:

Bachelors degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences.

Required Experience:

• 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.

Preferred Experience:

• Experience working with electronic regulatory submissions and data standards, prior experience in a regulatory affairs strategy role preferred.
• Experience with large cross-functional master data governance projects.
• Interest in advocacy as an Abb Vie representative in industry forums related to the global implementation of…