Director, Global Regulatory Data Stewardship

6084-Janssen Research & Development, LLC Legal Entity; Horsham (PA); Hybrid; USD 150,000 - 259,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Director, Regulatory Data Office Leader. This hybrid role can be based in Horsham, PA; Raritan, NJ; or Titusville, NJ. Lead a global team of data stewards and govern the Regulatory Data Hub to enable trusted data for decision making across R&D, IT, DDSAI, and the enterprise.

You will establish data standards, drive governance across functions, and partner with Regulatory Knowledge and Process Excellence to transform data into strategic insights.

Qualifications

• Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent.
• Advanced degree (Master’s, Ph.D., PharmD) preferred.
• Minimum 10 years in a medium-to-large pharmaceutical/healthcare setting.
• Experience with regulatory data governance and data stewardship.
• At least 2 years of people management experience.
• Strong data analysis and governance knowledge.
• Familiarity with regulatory systems and standards (Veeva/IDMP/SPOR/xEVMPD).
• Excellent communication and stakeholder management.

Responsibilities

• Lead data governance and stewardship for regulatory data.
• Promote accountability for data ownership and quality.
• Establish and maintain data governance policy and standards.
• Oversee regulatory data ownership and compliance with global requirements.
• Enable data stewards and domain owners across data domains.
• Chair Regulatory Data Council and align with enterprise governance.
• Own Regulatory Data Hub operations and data product alignment.
• Drive end-to-end RIM transformation with URP and AI tooling.
• Provide leadership for a global, matrix team.

Skills

Regulatory leadership

Compliance management

Regulatory affairs

Leadership

Data governance

Data analysis

Change management

Strategic thinking

Education

Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent

Advanced degree Master’s, Ph.D., PharmD (preferred)

Tools

Veeva Vault RIM

IDMP

SPOR

xEVMPD

Job description

Johnson & Johnson Innovative Medicine is seeking a Director, Regulatory Data Office Leader. This hybrid role can be based in Horsham, PA; Raritan, NJ; or Titusville, NJ. Lead a global team of data stewards and govern the Regulatory Data Hub to enable trusted data for decision making across R&D, IT, DDSAI, and the enterprise.

You will establish data standards, drive governance across functions, and partner with Regulatory Knowledge and Process Excellence to transform data into strategic insights.