Johnson & Johnson · 19 hours ago
Director, R&D Data Science, Data Products - Global Regulatory Affairs
Titusville, NJ
Full-time
Onsite
Director/Executive
$164K/yr - $283K/yr
8+ years expJohnson & Johnson is a leader in healthcare innovation dedicated to improving health outcomes. The Director, R&D Data Science, Data Products - Global Regulatory Affairs will lead the strategy and execution of data products that enable advanced analytics and AI/ML solutions, ensuring compliance and efficiency in regulatory submissions.
Hospital & Health Care
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
Contribute to the development and governance of a Global Regulatory Affairs Ontology to enable semantic consistency across submission, compliance, and intelligence domains
Align the Global Regulatory Affairs Ontology with enterprise metadata standards and external frameworks (e.g., ICH, IDMP, eCTD)
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
Collaborate with Global Regulatory Affairs and Data Science & Digital Health stakeholders to co-create solutions that maximize the value of regulatory data assets
Interface with technology and compliance teams to ensure data products meet global submission standards, transparency requirements, and health authority regulations
Lead a cross-functional team of product owners, data engineers, and Global Regulatory Affairs domain experts
Establish governance models, agile delivery processes, and value-tracking metrics for Global Regulatory Affairs data products
Define and track KPIs to measure the impact of data products on submission timelines, compliance risk reduction, and operational efficiency
Communicate product vision, roadmap, and value realization to Global Regulatory Affairs leadership, Data Science teams, and executive stakeholders
Champion data literacy and adoption within the Global Regulatory Affairs organization
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
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
Qualification
Required
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, labelling, intelligence, and compliance datasets
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
Data Product Management, Global Regulatory Submissions
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase