The role
03Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Regulatory Data Office Leader. This position is a hybrid role and will be located in Allschwil, Switzerland. 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.
01Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data.
02Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making.
03Establish 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.
04Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR).
05Enable 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.
06Operate and chair the cross-functional Regulatory Data Council, governing access to and ingestion of regulatory data and harmonizing with enterprise data governance frameworks.
07Reconcile central, regional, and local GRA business needs while ensuring overall efficiency and quality.
08Provide day-to-day business functional ownership of the Regulatory Data Hub (RDH), turning fragmented regulatory data into trusted, curated regulatory data for decision making.
09Provide governance and stewardship through the Regulatory Data Council to align GRA data domains with data products.
10Collaborate with JJT (IT) and DDSAI to enable consistent management and effective use of regulatory data across a range of business use cases.
11Provide 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.
12Anticipate business needs and evolve data and technology capabilities ahead of industry trends.
13Provide 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.
14Partner 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.
15Lead and develop a global team of data stewards and experts through direct and indirect reporting relationships.
16Establish clear data domain accountabilities and priorities, create individual and team capability development plans, and set measurable performance expectations aligned with business needs.
17Provide customer-focused leadership that empowers, promotes, and motivates high-performing teams, drives innovation, and fosters collaboration and diversity to deliver results.
