Director, Regulatory Data Office

Johnson & Johnson

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

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 standards, and drive strategic initiatives for data integrity and quality.

Highest-signal resume keywords

Regulatory Data GovernanceData StewardshipData AnalysisPeople ManagementRegulatory Affairs Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data StandardsData ArchitectureQuality Management PrinciplesIssue ResolutionProject LeadershipRoot-Cause AnalysisMetrics EstablishmentData QualityMetadata ManagementRegulatory Compliance

Soft Skills

Influencing Without AuthorityRelationship-BuildingConflict ResolutionNegotiationCommunication

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
Advocate for regulatory data integrity, quality, trustworthiness, and responsible stewardship
Establish and maintain data governance policies, standards, definitions, and business rules
Oversee regulatory data ownership and stewardship for accuracy, consistency, and global health authority compliance
Enable data stewards and domain owners to establish metrics, conduct root-cause analysis, prioritize remediation, and measure improvement
Chair the cross-functional Regulatory Data Council
Reconcile central, regional, and local GRA business needs
Provide day-to-day business ownership of the Regulatory Data Hub
Collaborate with IT and Data, Data Science and Artificial Intelligence teams on regulatory data use cases
Provide strategic input to tools and processes for collecting, sharing, submitting, and tracking regulatory data
Lead data governance and stewardship for Unified Regulatory Platform transformation
Support submission-excellence, AI, automation, simulation, eLabeling, and MDM 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 insights

Requirements

What you’ll need

Minimum Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent
Minimum 10 years of experience in a medium-to-large-scale Pharmaceutical, Medtech, or related healthcare environment
Foundation of Regulatory Affairs knowledge
Minimum 2 years of people management experience
Experience 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 data standards, data architecture/tools, and 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 data stewards or data governance in a regulated environment
Preferred: understanding of regulatory processes across 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 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