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

Role Summary

The Director, Data Products - Global Regulatory Affairs leads the strategy, design, and delivery of user-centric data products that enable advanced analytics, data science, and AI/ML solutions across Global Regulatory Affairs. The role ensures high-value regulatory data assets—such as submission data, health authority correspondence, labeling, regulatory intelligence, and real-world data—are standardized, productized, and integrated into J&J’s enterprise R&D data ecosystem, producing AI-ready, semantically consistent, interoperable data products that accelerate submissions and enhance compliance. Location: Spring House, PA (primary); Titusville, NJ considered.

Responsibilities

• Lead a team to define and deliver data products addressing critical Global Regulatory Affairs use cases (e.g., submission planning, health authority commitment tracking, labelling management, regulatory intelligence analysis).
• Define and maintain a roadmap for Global Regulatory Affairs data products, spanning pre-submission activities through post-market surveillance.
• Develop data products through agile delivery and FAIR data principles, ensuring scalability, interoperability, and reuse across Janssen functions and with health authorities.
• Integrate internal and external Global Regulatory Affairs data sources, including health authority databases, regulatory intelligence feeds, and submission archives.

Qualifications

• Experience
• 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, labelling, intelligence, and compliance datasets.

Education

• PhD or Master's in informatics, computer science, life sciences, or related discipline.

Skills

• Deep knowledge of Global Regulatory Affairs processes, submission pathways (e.g., eCTD), and global health authority requirements.
• Deep knowledge of data products, database design, and data transformation/mapping.
• Familiarity with metadata management, ontologies, knowledge graphs, and industry standards (e.g., IDMP, xEVMPD, ICH, eCTD).
• Strong leadership, collaboration, and communication skills, with the ability to translate technical strategy into business/science value.
• Demonstrated ability to influence stakeholders and drive adoption of new data capabilities across a complex organization.

Additional Requirements

• Travel up to 25%.