Director, R&D Data Science, Data Products - Global Regulatory Affairs

Role Summary

Director, Data Products - Global Regulatory Affairs. Lead the strategy, design, and delivery of user-centric, reusable data products enabling advanced analytics, data science, and AI/ML solutions across Global Regulatory Affairs. Ensure high-value internal and external regulatory data assets—submission data, health authority correspondence, labeling, regulatory intelligence, and real-world data (RWD/RWE)—are standardized, productized, and integrated into Janssen's enterprise R&D data ecosystem. Data products are AI-ready, semantically consistent, and interoperable to enable submission efficiency, enhanced compliance, and accelerated approvals. Location: Spring House, PA or Titusville, NJ. Up to 25% travel.

Responsibilities

• Data Product Strategy & Execution: Lead a team to define and deliver data products addressing critical Global Regulatory Affairs use cases (e.g., submission planning, health authority commitment tracking, labeling management, regulatory intelligence analysis).
• Data Product Strategy & Execution: Define and maintain a roadmap for Global Regulatory Affairs data products, spanning pre-submission activities through post-market surveillance.
• Data Product Strategy & Execution: Develop data products through agile delivery and FAIR data principles, ensuring scalability, interoperability, and reuse across Janssen functions and with health authorities.
• Data Product Strategy & Execution: Integrate internal and external Global Regulatory Affairs data sources, including health authority databases, regulatory intelligence feeds, and submission archives.
• Ontology & Semantic Modelling: Contribute to the development and governance of a Global Regulatory Affairs Ontology to enable semantic consistency across submission, compliance, and intelligence domains.
• Ontology & Semantic Modelling: Align the Global Regulatory Affairs Ontology with enterprise metadata standards and external frameworks (e.g., ICH, IDMP, eCTD).
• Collaboration & Integration: Partner with Knowledge Management, Data Product Architecture & Governance, and Master Data Management teams to ensure Global Regulatory Affairs data products integrate seamlessly into enterprise ontologies, knowledge graphs, and catalogues.
• Collaboration & Integration: Collaborate with Global Regulatory Affairs and Data Science & Digital Health stakeholders to co-create solutions that maximize the value of regulatory data assets.
• Collaboration & Integration: Interface with technology and compliance teams to ensure data products meet global submission standards, transparency requirements, and health authority regulations.
• Team & Operating Model Leadership: Lead a cross-functional team of product owners, data engineers, and Global Regulatory Affairs domain experts.
• Team & Operating Model Leadership: Establish governance models, agile delivery processes, and value-tracking metrics for Global Regulatory Affairs data products.
• Value Realization & Communication: Define and track KPIs to measure the impact of data products on submission timelines, compliance risk reduction, and operational efficiency.
• Value Realization & Communication: Communicate product vision, roadmap, and value realization to Global Regulatory Affairs leadership, Data Science teams, and executive stakeholders.
• Value Realization & Communication: Champion data literacy and adoption within the Global Regulatory Affairs organization.
• Strategic Impact: The Director, Data Products - Global Regulatory Affairs ensures Global Regulatory Affairs data is transformed into trusted, AI-ready products that accelerate submissions, enhance compliance, and provide critical regulatory insights.
• Strategic Impact: By embedding semantic rigor and aligning with enterprise data strategy, this role positions Global Regulatory Affairs data as a strategic asset that enables submission excellence, proactive compliance, and innovation across J&J R&D.

Qualifications

• PhD or Master's in informatics, computer science, life sciences, or related discipline.
• 8+ years of experience in pharma/biotech R&D with a focus on Global Regulatory Affairs, regulatory operations, regulatory technology, or data product management.
• Strong track record in data product development, integration, or semantic modelling in a regulated domain.
• Experience working with multi-modal regulatory data, including submission, labeling, intelligence, and compliance datasets.

Skills

• Required Skills: Data Product Management, Global Regulatory Submissions
• Preferred Skills: Advanced Analytics, Budget Management, Compliance Management, Critical Thinking, Data Analysis, Data Privacy Standards, Data Quality, Data Reporting, Data Savvy, Data Science, Data Visualization, Developing Others, Digital Fluency, Leadership, Ontology, Program Management, Semantic Modeling, Strategic Thinking, Succession Planning

Additional Requirements

• Travel up to 25%.