Director, Regulatory Data Office Leader

Global Regulatory Affairs (GRA) is seeking an experienced leader with deep regulatory domain expertise and a strong track record in data stewardship and governance. The Director, Regulatory Data Office Leader, will lead a global team of data stewards and oversee the Regulatory Data Hub (RDH), ensuring trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making as we build a world-class regulatory operations organization. As the business owner of GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards, the Director will strengthen the quality, integrity, accessibility, and responsible use of GRA data. This highly collaborative and technically fluent leader will partner across R&D, Johnson & Johnson Technology (IT), Data, Data Science and Artificial Intelligence (DDSAI), and the enterprise to establish governance policies and standards and to embed trusted data into major transformation efforts. This will include end-to-end Regulatory Information Management (RIM) through the Unified Regulatory Platform (URP), R&D Digital Solutions Initiative (i.e. MDM), eLabeling and submission-excellence AI tooling. Regulatory Knowledge and Process Excellence (RKPE) operates through three integrated pillars - the Data Office, the Process Office, and Decision Enablement. As leader of the Data Office, the Director will be accountable not only for the performance of their own pillar but for actively creating synergy across all three, ensuring that trusted data, well-designed process, and decision enablement operates as one connected capability rather than three separate functions.

Principal Responsibilities:

Data Governance and Stewardship

• Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data.
• Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making.
• Establish and maintain data governance policy, standards, definitions, and business rules for regulatory data across systems, in close alignment with R&D, Pharma, and cross-sector initiatives.
• Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR).
• Enable Data Stewards and Domain Owners to establish and monitor regulatory data quality metrics, lead root-cause analysis, prioritize remediation, and measure sustained improvement across regulatory data domains.

Data Council and Framework Leadership

• Operate and chair the cross-functional Regulatory Data Council, governing access to and ingestion of regulatory data and harmonizing with enterprise data governance frameworks.
• Reconcile central, regional, and local GRA business needs while ensuring overall efficiency and quality.

Regulatory Data Hub - Business Ownership

• Provide day-to-day business functional ownership of the Regulatory Data Hub (RDH), turning fragmented regulatory data into trusted, curated regulatory data for decision making.
• Provide governance and stewardship through the Regulatory Data Council to align GRA data domains with data products. Collaborate with JJT (IT) and DDSAI to enable consistent management and effective use of regulatory data across a range of business use cases.
• Provide strategic input to current and future tools and processes used to collect, share, submit, and track regulatory data, ensuring related business support and services are provided to the GRA community.
• Anticipate business needs and evolve data and technology capabilities ahead of industry trends.

Transformation Enablement

• Provide strategic leadership to engage and support end-to-end RIM transformation through the Unified Regulatory Platform (URP), ensuring data governance, quality, and stewardship requirements are embedded from design through adoption.
• Partner on submission-excellence and next-generation submission efforts, supporting the responsible adoption of AI, automation, and simulation capabilities with trusted, well-governed data as the foundation.
• GRA leader and enabler of success across programs representing a broader transformation landscape that will require thoughtful strategy, silo elimination, and alignment across R&D and the enterprise (e.g. eLabeling, MDM/DSI).
• Stay attuned to the impact of global initiatives and direct regulatory contributions to the implementation strategy for globally developed regulatory authority programs.

Leadership and People Management

• Lead and develop a global team of data stewards and experts t