Director, Regulatory Data Office Leader

Johnson & Johnson Innovative Medicine; Leiden; Hybrid; EUR 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, is seeking a Director, Regulatory Data Office Leader for a hybrid role located in Beerse, Belgium or Leiden, Netherlands.

The role leads the Global Regulatory Affairs data governance program, oversees the Regulatory Data Hub, and chairs the Regulatory Data Council to enable trusted data for analytics and decision-making.

Qualifications

• Experience in data governance and regulatory data stewardship.
• Ability to lead cross-functional teams and define governance policies.
• Strong collaboration with R&D, IT and data science teams.

Responsibilities

• Data Governance and Stewardship: advocate for data integrity and ownership; ensure quality and access across systems.
• Data Council and Framework Leadership: chair Regulatory Data Council and harmonize with enterprise governance.
• Regulatory Data Hub - Business Ownership: manage the Regulatory Data Hub, ensure trusted regulatory data for decisions.
• Transformation Enablement: lead end-to-end RIM transformation and enable AI tooling with trusted data.

Job description

• Switzerland - Requisition Number: R-100196

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Product Submissions and Registration

Job Category

People Leader

All Job Posting Locations:

Beerse, Antwerp, Belgium, Leiden, Netherlands

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-098239
• United Kingdom - Requisition Number: R-100188
• Belgium, Netherlands - Requisition Number: R-100190
• Switzerland - Requisition Number: R-100196

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Regulatory Data Office Leader. This position is a hybrid role and can be located in Beerse, Belgium or Leiden, Netherlands.

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.