Director, Regulatory Data Office

Johnson & Johnson

. Lead a global team of data stewards and oversee the Regulatory Data Hub (RDH) .

Posted 9/16/2026full-timeHorsham • New Jersey • United StatesSenior💰 $150,000 - $258,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Data Governance, ensuring high-quality regulatory data management and compliance with global health authority requirements. Proven ability to lead cross-functional teams, influence stakeholders, and drive strategic initiatives in a regulated environment.

Highest-signal resume keywords

Regulatory Data GovernanceData StewardshipData Quality ManagementRegulatory Affairs KnowledgeProject Leadership

ATS Keywords

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Hard Skills

Data AnalysisData StandardsData ArchitectureQuality Management PrinciplesRegulatory ComplianceMetadata ManagementIssue ResolutionAI-Enabled ToolingDigital TransformationAgile Methodologies

Soft Skills

Influencing Without AuthorityRelationship BuildingConflict ResolutionNegotiation SkillsVerbal Communication

Tools & Technologies

Veeva Vault RIMIDMPSPORXEVMPDUnified Regulatory Platform

Certifications & Qualifications

Bachelor’s DegreeAdvanced Degree Preferred

Industry Keywords

PharmaceuticalMedtechHealthcareRegulated EnvironmentR&D

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead a global team of data stewards and oversee the Regulatory Data Hub (RDH)
Ensure trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making
Own GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards
Establish governance policies, standards, definitions, and business rules for regulatory data
Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements
Enable Data Stewards and Domain Owners to establish and monitor data quality metrics, conduct root-cause analysis, prioritize remediation, and measure improvement
Chair the cross-functional Regulatory Data Council and govern access to and ingestion of regulatory data
Reconcile central, regional, and local GRA business needs
Provide day-to-day business functional ownership of the Regulatory Data Hub
Collaborate with JJT (IT) and DDSAI to manage and use regulatory data across business use cases
Provide strategic input to tools and processes used to collect, share, submit, and track regulatory data
Lead and support end-to-end RIM transformation through the Unified Regulatory Platform
Support submission-excellence and next-generation submission efforts involving AI, automation, and simulation
Drive alignment across R&D and the enterprise, including eLabeling and MDM/DSI initiatives
Lead and develop a global team through direct and indirect reporting relationships
Set data domain accountabilities, priorities, capability development plans, and performance expectations
Partner with Process Office and Decision Enablement leads to connect data standards, process design, and decision-ready insights

Requirements

What you’ll need

A minimum of a Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent is required
A minimum of 10 years of experience in a medium-to-large-scale Pharmaceutical, Medtech or related healthcare environment
Foundation of Regulatory Affairs knowledge
A minimum of 2 years of people management experience
Experience serving as a data steward, lead data steward, data-domain governance lead, or equivalent business owner accountable for data standards, quality, metadata, ownership, and issue resolution in a regulated environment
Strong data analysis skills and ability to translate data into information and strategies into actionable plans
Strong understanding of data standards, data architecture/tools, and related governance
Knowledge of quality management and/or compliance principles within the drug development process
Experience leading projects and project teams
Ability to influence without authority and drive alignment in a global, matrix environment
Ability to build trust with cross-functional stakeholders
Excellent verbal and written communication skills
Strong networking, relationship-building, conflict-resolution, and negotiation skills
Advanced degree (Master’s, Ph.D., PharmD) preferred
Hands-on knowledge of regulatory systems and standards, such as Veeva Vault RIM, IDMP, SPOR, xEVMPD, and structured content preferred
Experience leading a team of data stewards or leading data governance in a regulated environment preferred
Understanding of how regulatory processes interconnect with R&D, clinical, safety, and supply chain preferred
Experience supporting digital transformation, agile/rapid value-realization concepts, and AI-enabled tooling preferred

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
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 birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview accommodations
Hybrid work arrangement