Sr Director, Global Leader, Regulatory Data & Process Excellence

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere 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 athttps:// 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 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 bridgingregulatory domain and process expertisewithR&D data science capabilitiesto 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 theglobal regulatory data strategy ensuring alignment with enterprise data and digital priorities.
• Establishand/or harmonize with data governance frameworks standards processes and requirements for regulatory data across systems.
• Oversee regulatory dataownership 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 thebusiness ownerof theRegulatory 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 thedata architecture taxonomy and semantic interoperabilityto support current needs and future AI/analytics use cases.

Data Interpretation & Insights

• Lead a team ofdata interpreters/analystswho transform regulatory data intoactionable insights and KPIsthat inform planning submission strategy and resource forecasting.
• Partner with regulatory affairs leadership to embeddata-driven decision-makingin 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 toco-create AI/ML solutions
• Ensure regulatory data and AI/ML use cases adhere tocompliance traceability and auditability standards(GxP internal policies).

Leadership & Influence

• Act as achange agent fostering a culture ofdata excellence and digital innovationwithin Global Regulatory Affairs (GRA).
• Build and develop ahigh-performing data teamwith capabilities in stewardship interpretation and governance.
• Influence across R&D functions to driveenterprise-wide data connectivity and reuse.
• Drive strategic discussions and alignment on data considerations within the GRA Portfolio.

Qualifications

• Bachelors degree in scientific or technical discipline Regulatory Affairs Life Sciences or a related field required. A masters 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. The anticipated pay range is $173000- $299000.

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 Companys 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. & 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 () or contact AskGS to be directed to your accommodation resource.