Sr Director, Global Leader, Regulatory Data & Process ExcellenceJ&J Family of Companies • Washington Crossing, PA, US

Sr Director, Global Leader, Regulatory Data & Process Excellence

J&J Family of Companies • Washington Crossing, PA, US

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Sr Director, Global Leader, Regulatory Data & Process Excellence

Johnson & Johnson is recruiting for the Sr Director, Global Leader, Regulatory Data & Process Excellence located at either Raritan, NJ, Titusville, NJ, Spring House, PA, Horsham, PA, Allschwil, CH, or Beerse, BE.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

The Sr Director, Global Leader, Regulatory Data & Process Excellence is responsible for defining and executing the regulatory data & process strategy for the organization while maximizing the value of regulatory data as a strategic asset. By leveraging a close partnership with both R&D Data Science & Digital Health (DSDH) and Information Technology (JJT), this role will ensure that regulatory data is governed, trusted, and strategically leveraged to drive compliance, operational efficiency, and innovation. In addition, this role will drive business process design, optimization, and next-generation submission transformation.

This role is pivotal in bridging regulatory domain and process expertise with R&D data science capabilities to enable data-driven decision-making and AI-enabled regulatory operations.

Responsibilities include, but are not limited to the following :

Define and lead the global regulatory data strategy, ensuring alignment with enterprise data and digital priorities.
Establish and / or harmonize with data governance frameworks, standards, processes, and requirements for regulatory data across systems.
Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (IDMP, xEVMPD, SPOR).
Maintain regulatory domain expertise, regulatory compliance, and business outcome accountability.
Enforce ALCOA+ principles and data integrity standards.
Direct the design, harmonization, and continuous improvement of regulatory processes across markets and functions.
Ensure processes align with Veeva RIM capabilities, enabling sustainable adoption and efficiency.
Act as the business owner of the Regulatory Data Hub (RDH), partnering with JJT and R&D Data Science & Digital Health to ensure data is structured, accessible, and integrated with enterprise platforms.
Shape the data architecture, taxonomy, and semantic interoperability to support current needs and future AI / analytics use cases.
Lead a team of data interpreters / analysts who transform regulatory data into actionable insights and KPIs that inform planning, submission strategy, and resource forecasting.
Partner with regulatory affairs leadership to embed data-driven decision-making in operational and strategic processes.
Scale a capability dedicated to automation and submission simulation.
Partner with R&D Data Science & Digital Health and URP to bring next-generation submission models into practice.
Serve as a member of the R&D Data Science & Digital Health Global Functions leadership team, ensuring regulatory priorities and nuances are represented.
Collaborate with R&D Data Science & Digital Health to co-create AI / ML solutions.
Ensure regulatory data and AI / ML use cases adhere to compliance, traceability, and auditability standards (GxP, internal policies).
Act as a change agent, fostering a culture of data excellence and digital innovation within Global Regulatory Affairs (GRA).
Build and develop a high-performing data team with capabilities in stewardship, interpretation, and governance.
Influence across R&D functions to drive enterprise-wide data connectivity and reuse.
Drive strategic discussions and alignment on data considerations within the GRA Portfolio.

Qualifications :

Bachelor's degree in scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field, required. A master's degree or higher is preferred and will be viewed favorably.

10+ years overall work experience with at least 8 years in pharmaceutical or healthcare industry, required.

People or team management experience required.

Familiarity with the following is preferred :

AI / ML, data science principles, and analytics platforms

Data lineage

Master data management

Data quality frameworks

Metadata management

Cataloguing

Process mapping and redesign

Knowledge of regulatory systems and standards (RIM platforms, IDMP, SPOR, structured content), required.

Understanding of how regulatory processes interconnect with R&D, clinical, safety, and supply chain, required.

Excellent analytical skills with diligence and effective communication at all levels, required.

Demonstrated ability to translate data into information, and strategies into actionable plans, required.

Proven ability to influence senior levels, lead cross-functional initiatives, and drive cultural change, required.

Exceptional communication and storytelling skills to translate complex data into business-relevant insights, required.

Fosters a culture of support and collaboration, required.

Commitment to Our Credo, Diversity, Equity & Inclusion (who we are and what we believe) by ensuring we are attracting, developing and retaining talent that reflects the communities our teams serve, required.

Focuses on business agility, agile delivery with a fail-fast mindset, and measurable outcomes, required.

Strong leader, collaborator, and individual contributor, required.

Strong problem-solving skills with a focus on innovation and continuous improvement, required.

Experience working in a global, matrixed organization, required.

Expect travel up to 20% including domestic and international.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar / performance year. Bonuses are awarded at the Company's discretion on an individual basis. The anticipated pay range is $173,000- $299,000.

Employees and / or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits :

Vacation - up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work

Personal and Family Time - up to 40 hours per calendar year

Volunteer time - up to 24 hours per calendar year

Additional information can be found through the link below.

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Director Regulatory • Washington Crossing, PA, US