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

Filled
February 23, 2026
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Job Description

Company: Johnson & Johnson
Locations: Spring House, PA or Titusville, NJ
Salary Range: $164,000 – $282,900 USD
Travel: Up to 25%

🎯 Role Overview

This is a senior leadership position focused on transforming regulatory data into AI-ready, reusable data products across Global Regulatory Affairs (GRA). The role sits at the intersection of:

  • Data science
  • Regulatory operations
  • Data product management
  • Semantic modeling / ontology
  • Enterprise R&D data strategy

The ultimate goal is to accelerate drug approvals, improve compliance, and enable advanced analytics by standardizing and integrating regulatory datasets across the organization.

🧠 Core Responsibilities

1️⃣ Data Product Strategy & Delivery

  • Define roadmap for regulatory data products spanning:
    • Submission planning
    • Health authority communication
    • Labeling management
    • Regulatory intelligence
    • Post-market surveillance
  • Ensure data follows FAIR principles (Findable, Accessible, Interoperable, Reusable).
  • Integrate internal and external regulatory data sources into enterprise platforms.

2️⃣ Ontology & Semantic Modeling

  • Contribute to Global Regulatory Affairs ontology development.
  • Align with industry standards such as:
    • eCTD
    • IDMP
    • ICH frameworks
  • Enable semantic consistency and interoperability across systems.

3️⃣ Cross-Functional Leadership

  • Partner with:
    • Regulatory teams
    • Submission management
    • Data science & digital health groups
    • Knowledge management & architecture teams
  • Ensure data products integrate into enterprise knowledge graphs and metadata systems.

4️⃣ Team & Operating Model

  • Lead a multidisciplinary team:
    • Product owners
    • Data engineers
    • Domain experts
  • Establish governance, agile processes, and value tracking.

5️⃣ Business Impact & Communication

  • Define KPIs tied to:
    • Submission speed
    • Compliance risk reduction
    • Operational efficiency
  • Present strategy and impact to executives.
  • Drive adoption and data literacy across regulatory teams.

✅ Required Profile

Education

  • PhD or Master’s in:
    • Informatics
    • Computer Science
    • Life Sciences
    • Related discipline

Experience

  • 8+ years in pharma/biotech R&D with regulatory or data focus.
  • Experience in:
    • Data product development
    • Regulatory submissions (eCTD, etc.)
    • Semantic modeling / ontologies
    • Multi-modal regulatory datasets

Technical & Leadership Skills

  • Regulatory domain expertise (global health authorities).
  • Data architecture and transformation knowledge.
  • Metadata management and knowledge graph familiarity.
  • Strong stakeholder influence and organizational leadership.

🌍 Strategic Importance of This Role

This is a high-impact enterprise role because regulatory data is one of the most complex and valuable datasets in pharma. Success in this position can:

  • Shorten drug approval timelines
  • Reduce compliance risk
  • Enable AI-driven regulatory intelligence
  • Improve cross-functional R&D collaboration

It’s essentially a Director of Data Products + Regulatory Data Strategy hybrid.

💼 Career Level Insight

This role typically fits candidates with backgrounds such as:

  • Director / Senior Manager in pharma data science
  • Regulatory technology leaders
  • Data product leaders in life sciences
  • R&D informatics leaders
  • Consulting leaders (life sciences domain)

It is not an individual contributor role — leadership and strategy are critical.