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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. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub** **Function:

Regulatory Product Submissions and Registration

Job Category:

People Leader

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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. Learn more at https://www.jnj.com/.

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. A key member of the **Regulatory Operations & Digital Innovation** ( **RODI) Senior Leadership Team** , this role is critical to providing business ownership of the Regulatory Data Hub (RDH), overseeing data stewardship and interpretation, partnering with the **Unified Regulatory Platform (URP) team** , and serving as the primary regulatory partner with the **R&D Data Science & Digital Health** leadership team.

This role will lead a **Regulatory Data & Process Excellence team** responsible for shaping, governing, and evolving the regulatory data and process ecosystem to enable compliant, efficient, and innovation-driven regulatory operations. It will ensure that regulatory data is accurate, actionable, and aligned with GRA objectives, regulatory requirements, and digital transformation initiatives. This team will equip GRA with the power of digital solutions by:

+ Driving data-centric regulatory use-case development

+ Identifying the business problems and regulatory nuances

+ Acting as an engagement layer between GRA and DSDH to ensure that our most critical questions are transformed into data-driven solutions.

+ Championing the quality, integrity, and trustworthiness of GRA data.

+ Acting as the data domain expert

+ Owning the business context, quality, and governance of regulatory data

+ Aligning process design with data strategy

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:

Regulatory Data Strategy & Governance

+ 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

Process Excellence

+ 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.

Regulatory Data Hub Ownership

+ 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.

Data Interpretation & Insights

+ 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.

Submissions Transformation & Innovation

+ 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.

R&D Data Science** **Partnership

+ 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).

Leadership & Influence

+ 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. Preferences for the following:

+ Strong track record in pharmaceutical, healthcare, or regulatory affairs.

+ Demonstrated experience in data governance, data quality, data strategy and process excellence within a regulated environment.

+ Internal and external resource management experience.

+ Experience with agile / rapid value realization concepts.

+ 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. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.