Johnson & Johnson Innovative Medicine
Sr Director, Global Leader, Regulatory Data & Process Excellence
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Sr Director, Global Leader, Regulatory Data & Process Excellence
Join to apply for the
Sr Director, Global Leader, Regulatory Data & Process Excellence
role at
Johnson & Johnson Innovative Medicine .
Job Location: Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Allschwil, CH; Beerse, BE.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: People Leader
Job Description 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. The role will partner with R&D Data Science & Digital Health (DSDH) and Information Technology (JJT) to ensure regulatory data is governed, trusted, and strategically leveraged to drive compliance, operational efficiency, and innovation. The role will lead business process design, optimization and next-generation submission transformation. It is a key member of the Regulatory Operations & Digital Innovation (RODI) Senior Leadership Team.
Responsibilities
Define and lead the global regulatory data strategy, ensuring alignment with enterprise data and digital priorities.
Establish and harmonize 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 structure, access, and integrate data 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.
Collaborate 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.
Co‑create AI/ML solutions with R&D Data Science & Digital Health.
Ensure regulatory data and AI/ML use cases adhere to compliance, traceability, and auditability standards.
Act as a change agent, fostering a culture of data excellence and digital innovation within Global Regulatory Affairs.
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 a scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field, required. Master’s degree or higher is preferred.
10+ years overall work experience with at least 8 years in pharmaceutical or healthcare industry, required.
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 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).
Understanding of how regulatory processes interconnect with R&D, clinical, safety and supply chain.
Excellent analytical skills with diligence and effective communication at all levels.
Demonstrated ability to translate data into information and strategies into actionable plans.
Proven ability to influence senior levels, lead cross‑functional initiatives, and drive cultural change.
Exceptional communication and storytelling skills to translate complex data into business‑relevant insights.
Commitment to Our Credo, Diversity, Equity & Inclusion.
Focus on business agility, agile delivery with a fail‑fast mindset, and measurable outcomes.
Strong leader, collaborator, and individual contributor.
Strong problem‑solving skills with a focus on innovation and continuous improvement.
Experience working in a global, matrixed organization.
Travel Expect travel up to 20% including domestic and international.
Compensation Annual performance bonus eligible. Pay range: $173,000 – $299,000.
Benefits
Medical, dental, vision, life insurance, short‑ and long‑term disability, and business accident insurance.
Pension and 401(k) retirement plan.
Vacation up to 120 hours per calendar year.
Sick time up to 40 hours per calendar year (56 hours in Washington state).
Holiday pay, including floating holidays, up to 13 days per calendar year.
Personal and family time up to 40 hours per calendar year.
Volunteer time up to 24 hours per calendar year.
Equal Opportunity Employment 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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Sr Director, Global Leader, Regulatory Data & Process Excellence
role at
Johnson & Johnson Innovative Medicine .
Job Location: Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Allschwil, CH; Beerse, BE.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Product Submissions and Registration
Job Category: People Leader
Job Description 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. The role will partner with R&D Data Science & Digital Health (DSDH) and Information Technology (JJT) to ensure regulatory data is governed, trusted, and strategically leveraged to drive compliance, operational efficiency, and innovation. The role will lead business process design, optimization and next-generation submission transformation. It is a key member of the Regulatory Operations & Digital Innovation (RODI) Senior Leadership Team.
Responsibilities
Define and lead the global regulatory data strategy, ensuring alignment with enterprise data and digital priorities.
Establish and harmonize 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 structure, access, and integrate data 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.
Collaborate 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.
Co‑create AI/ML solutions with R&D Data Science & Digital Health.
Ensure regulatory data and AI/ML use cases adhere to compliance, traceability, and auditability standards.
Act as a change agent, fostering a culture of data excellence and digital innovation within Global Regulatory Affairs.
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 a scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field, required. Master’s degree or higher is preferred.
10+ years overall work experience with at least 8 years in pharmaceutical or healthcare industry, required.
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 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).
Understanding of how regulatory processes interconnect with R&D, clinical, safety and supply chain.
Excellent analytical skills with diligence and effective communication at all levels.
Demonstrated ability to translate data into information and strategies into actionable plans.
Proven ability to influence senior levels, lead cross‑functional initiatives, and drive cultural change.
Exceptional communication and storytelling skills to translate complex data into business‑relevant insights.
Commitment to Our Credo, Diversity, Equity & Inclusion.
Focus on business agility, agile delivery with a fail‑fast mindset, and measurable outcomes.
Strong leader, collaborator, and individual contributor.
Strong problem‑solving skills with a focus on innovation and continuous improvement.
Experience working in a global, matrixed organization.
Travel Expect travel up to 20% including domestic and international.
Compensation Annual performance bonus eligible. Pay range: $173,000 – $299,000.
Benefits
Medical, dental, vision, life insurance, short‑ and long‑term disability, and business accident insurance.
Pension and 401(k) retirement plan.
Vacation up to 120 hours per calendar year.
Sick time up to 40 hours per calendar year (56 hours in Washington state).
Holiday pay, including floating holidays, up to 13 days per calendar year.
Personal and family time up to 40 hours per calendar year.
Volunteer time up to 24 hours per calendar year.
Equal Opportunity Employment 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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