Director, Regulatory Data Office Leader

Leiden Bio Science Park; Netherlands; On-site; EUR 150,000 - 190,000; Full time

Job summary

Leiden Bio Science Park seeks an experienced Director, Regulatory Data Office Leader within Global Regulatory Affairs (GRA) to spearhead data governance for regulatory data, lead a global data steward team, and oversee the Regulatory Data Hub (RDH) ensuring data quality and trusted analytics for RIM programs.

The role chairs the Regulatory Data Council, partners across R&D, IT, and DDSAI, and drives governance policies, standards, and scalable data solutions to support enterprise decision-making

Qualifications

• Minimum 10 years of experience in a pharma/healthcare environment.
• Experience leading data governance in regulated environments.
• Strong data analysis skills and ability to translate data into insight.

Responsibilities

• Lead the Data Office and oversee the Regulatory Data Hub (RDH).
• Chair the Regulatory Data Council and align data with enterprise governance.
• Drive end-to-end RIM transformation via URP and AI-enabled tooling.
• Partner with R&D, IT, DDSAI, and broader enterprise to embed trusted data in decision making.

Skills

Data governance

Regulatory data

Leadership

Stakeholder management

Regulatory affairs

Data quality

Regulatory data standards

Education

Bachelor's degree in Science/Business/IT

Advanced degree preferred

Tools

Veeva Vault RIM

MDM

SQL

Job description

Global Regulatory Affairs (GRA) is seeking an experienced leader with deep regulatory domain expertise and a strong track record in data stewardship and governance. The Director, Regulatory Data Office Leader, will lead a global team of data stewards and oversee the Regulatory Data Hub (RDH), ensuring trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making as we build a world-class regulatory operations organization. As the business owner of GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards, the Director will strengthen the quality, integrity, accessibility, and responsible use of GRA data. This highly collaborative and technically fluent leader will partner across R&D, Johnson & Johnson Technology (IT), Data, Data Science and Artificial Intelligence (DDSAI), and the enterprise to establish governance policies and standards and to embed trusted data into major transformation efforts. This will include end-to-end Regulatory Information Management (RIM) through the Unified Regulatory Platform (URP), R&D Digital Solutions Initiative (i.e. MDM), eLabeling and submission-excellence AI tooling. Regulatory Knowledge and Process Excellence (RKPE) operates through three integrated pillars - the Data Office, the Process Office, and Decision Enablement. As leader of the Data Office, the Director will be accountable not only for the performance of their own pillar but for actively creating synergy across all three, ensuring that trusted data, well-designed process, and decision enablement operates as one connected capability rather than three separate functions.

Principal Responsibilities:

Data Governance and Stewardship

• Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data.
• Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making.
• Establish and maintain data governance policy, standards, definitions, and business rules for regulatory data across systems, in close alignment with R&D, Pharma, and cross-sector initiatives.
• Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR).
• Enable Data Stewards and Domain Owners to establish and monitor regulatory data quality metrics, lead root-cause analysis, prioritize remediation, and measure sustained improvement across regulatory data domains.

Data Council and Framework Leadership

• Operate and chair the cross-functional Regulatory Data Council, governing access to and ingestion of regulatory data and harmonizing with enterprise data governance frameworks.
• Reconcile central, regional, and local GRA business needs while ensuring overall efficiency and quality.

Regulatory Data Hub - Business Ownership

• Provide day-to-day business functional ownership of the Regulatory Data Hub (RDH), turning fragmented regulatory data into trusted, curated regulatory data for decision making.
• Provide governance and stewardship through the Regulatory Data Council to align GRA data domains with data products. Collaborate with JJT (IT) and DDSAI to enable consistent management and effective use of regulatory data across a range of business use cases.
• Provide strategic input to current and future tools and processes used to collect, share, submit, and track regulatory data, ensuring related business support and services are provided to the GRA community.
• Anticipate business needs and evolve data and technology capabilities ahead of industry trends.

Transformation Enablement

• Provide strategic leadership to engage and support end-to-end RIM transformation through the Unified Regulatory Platform (URP), ensuring data governance, quality, and stewardship requirements are embedded from design through adoption.
• Partner on submission-excellence and next-generation submission efforts, supporting the responsible adoption of AI, automation, and simulation capabilities with trusted, well-governed data as the foundation.
• GRA leader and enabler of success across programs representing a broader transformation landscape that will require thoughtful strategy, silo elimination, and alignment across R&D and the enterprise (e.g. eLabeling, MDM/DSI).
• Stay attuned to the impact of global initiatives and direct regulatory contributions to the implementation strategy for globally developed regulatory authority programs.

Leadership and People Management

• Lead and develop a global team of data stewards and experts through direct and indirect reporting relationships. establish clear data domain accountabilities and priorities, create individual and team capability development plans, and set measurable performance expectations aligned with business needs.
• Provide customer-focused leadership that empowers, promotes, and motivates high-performing teams, drives innovation, and fosters collaboration and diversity to deliver results.
• Contribute expertise to internal and external initiatives that influence evolving policy and requirements impacting regulatory data capabilities. Partner deliberately with the Process Office and Decision Enablement leads to connect data standards to process design and to translate governed data into decision-ready insight, jointly setting shared priorities, resolving interdependencies, and presenting an integrated RKPE agenda to stakeholders.

Education:

• A minimum of a Bachelor’s degree in Science, Business, Computer Science/Technology, Regulatory Affairs, or equivalent is required. Advanced degree Master’s, Ph.D., PharmD) preferred.

Required:

• A minimum of 10 years of experience in a medium-to-large-scale Pharmaceutical, Medtech or related healthcare environment.
• Experience with a foundation of Regulatory Affairs knowledge.
• A minimum of 2 years of people management experience.
• Demonstrated 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 with the ability to translate data into information, and strategies into actionable plans.
• 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.
• The ability to influence without authority and drive alignment in a global, matrix environment.
• The 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 regulatory systems and standards (e.g., Veeva Vault RIM, IDMP, SPOR, xEVMPD) and structured content.
• Experience leading a team of data stewards, or leading data governance in a regulated environment.
• Understanding of how regulatory processes interconnect with R&D, clinical, safety, and supply chain.
• Experience supporting digital transformation, agile/rapid value-realization concepts, and AI-enabled tooling.

Preferred Skills:

• Compliance Management
• Design Thinking
• Developing Others
• Inclusive Leadership
• Industry Analysis
• Leadership
• New Program Development
• Operations Management
• Package and Labeling Regulations
• Product Packaging Design
• Regulatory Affairs Management
• Regulatory Compliance
• Standard Operating Procedure (SOP)
• Strategic Thinking
• Sustainability
• Sustainable Packaging
• Transparency Reporting