Director, Regulatory Data Office Leader

Johnson & Johnson

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

Posted 9/17/2026full-timeBeerse • BelgiumSenior💰 €127,500 - €219,305 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory data governance, data stewardship, and compliance within the pharmaceutical and healthcare sectors. Proven ability to lead cross-functional teams, establish data quality metrics, and drive strategic initiatives for data management and transformation.

Highest-signal resume keywords

Regulatory Data GovernanceData StewardshipData Quality ManagementPeople ManagementRegulatory Affairs Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisData StandardsData ArchitectureQuality Management PrinciplesCompliance PrinciplesProject LeadershipIssue ResolutionMetadata ManagementRegulatory Data OwnershipRoot-Cause Analysis

Soft Skills

Influencing Without AuthorityRelationship-BuildingConflict ResolutionNegotiationCommunication Skills

Tools & Technologies

Veeva Vault RIMIDMPSPORXEVMPDAI-Enabled Tooling

Industry Keywords

PharmaceuticalMedtechHealthcareRegulated EnvironmentDigital Transformation

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)
Advocate for regulatory data integrity, business relevance, quality, trustworthiness, and responsible stewardship
Establish and maintain data governance policies, standards, definitions, and business rules
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 regulatory data access and ingestion
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 on regulatory data management and business use cases
Provide strategic input to tools and processes for collecting, sharing, submitting, and tracking regulatory data
Lead regulatory data governance for end-to-end RIM transformation through the Unified Regulatory Platform
Support submission-excellence and next-generation submission efforts, including responsible AI, automation, and simulation adoption
Partner across R&D and the enterprise on eLabeling, MDM/DSI, and other transformation initiatives
Lead and develop global data stewards and experts through direct and indirect reporting relationships
Partner with Process Office and Decision Enablement leads to connect data standards, process design, and decision-ready insight

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
Strong understanding of the business aspects 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
Preferred: hands-on knowledge of 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

Benefits

Comp & perks

Annual bonus with set target (% of pay) depending on pay grade / location, based on employee and company performance
Vacation days
Parental leave for a minimum of 12 weeks
Bereavement leave
Caregiver leave
Volunteer leave
Well-being reimbursement
Programs for financial, physical and mental health
Service anniversary and recognition awards
Insurance plans for employees and, in some locations, eligible dependents