Director, R&D Data Science, Data Products Global Regulatory Affairs

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

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Data Science

Job Category:

People Leader

All Job Posting Locations:

Spring House Pennsylvania United States of America Titusville New Jersey United States of America

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 are searching for the best talent for Director R&D Data Science Data Products - Global Regulatory Affairs.

Purpose:

The Director Data Products - Global Regulatory Affairs is responsible for leading the strategy design and delivery of user-centric reusable data products that enable advanced analytics data science and AI/ML solutions across theGlobal Regulatory Affairsorganization. This role ensures that high-value internal and externalregulatory data assets - including submission data health authority correspondence product labelling regulatory intelligence and real-world data (RWD/RWE) - are standardized productized and integrated into J&Js enterprise R&D data ecosystem.

Working closely with Global Regulatory Affairs teams Submission Management Regulatory Operations and Data Science stakeholders this leader ensures that Global Regulatory Affairs data products are AI-ready semantically consistent and interoperable enablingsubmission efficiency enhanced compliance and accelerated approvals.

You will be responsible for:

Data Product Strategy & Execution

• Lead a team to define and deliver data products addressing criticalGlobal Regulatory Affairs use cases(e.g. submission planning health authority commitment tracking labelling management regulatory intelligence analysis).

• Define and maintain a roadmap forGlobal Regulatory Affairs data products spanning pre-submission activities through post-market surveillance.

• Develop data products through agile delivery and FAIR data principles ensuring scalability interoperability and reuse across Janssen functions and with health authorities.

• Integrate internal and externalGlobal Regulatory Affairs data sources including health authority databases regulatory intelligence feeds and submission archives.

Ontology & Semantic Modelling

• Contribute to the development and governance of aGlobal Regulatory Affairs Ontologyto enable semantic consistency across submission compliance and intelligence domains.

• Align theGlobal Regulatory Affairs Ontologywith enterprise metadata standards and external frameworks (e.g. ICH IDMP eCTD).

Collaboration & Integration

• Partner with Knowledge Management Data Product Architecture & Governance and Master Data Management teams to ensureGlobal Regulatory Affairs data productsintegrate seamlessly into enterprise ontologies knowledge graphs and catalogues.

• Collaborate withGlobal Regulatory Affairs and Data Science & Digital Health stakeholders to co-create solutions that maximize the value of regulatory data assets.

• Interface with technology and compliance teams to ensure data products meet global submission standards transparency requirements and health authority regulations.

Team & Operating Model Leadership

• Lead a cross-functional team of product owners data engineers andGlobal Regulatory Affairs domain experts.

• Establish governance models agile delivery processes and value-tracking metrics forGlobal Regulatory Affairs data products.

Value Realization & Communication

• Define and track KPIs to measure the impact of data products onsubmission timelines compliance risk reduction and operational efficiency.

• Communicate product vision roadmap and value realization toGlobal Regulatory Affairs leadership Data Science teams and executive stakeholders.

• Champion data literacy and adoption within theGlobal Regulatory Affairs organization.

Strategic Impact

• The Director Data Products - Global Regulatory Affairs ensuresGlobal Regulatory Affairs datais transformed into trusted AI-ready products thataccelerate submissions enhance compliance and provide critical regulatory insights.

• By embedding semantic rigor and aligning with enterprise data strategy this role positionsGlobal Regulatory Affairs dataas a strategic asset that enablessubmission excellence proactive compliance and innovation across J&J R&D.

Qualifications / Requirements:

Education

• PhD or Masters in informatics computer science life sciences or related discipline.

Experience

• 8 years of experience in pharma/biotech R&D with a focus onGlobal Regulatory Affairs regulatory operations regulatory technology or data product management.

• Strong track record in data product development integration or semantic modelling in a regulated domain.

• Experience working with multi-modal regulatory data including submission labelling intelligence and compliance datasets.

Skills & Expertise

• Deep knowledge ofGlobal Regulatory Affairs processes submission pathways (e.g. eCTD) and global health authority requirements.

• Deep knowledge of data products database design and data transformation/mapping.

• Familiarity with metadata management ontologies knowledge graphs and industry standards (e.g.IDMP xEVMPD ICH eCTD).

• Strong leadership collaboration and communication skills with the ability to translate technical strategy into business/science value.

• Demonstrated ability to influence stakeholders and drive adoption of new data capabilities across a complex organization.

Other

• This position has a primary location of Spring House PA but is also open to Titusville position requires up to 25% travel.

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LIHybrid #JNJDataScience #JNJIMRND-DS

Required Skills:

Data Product Management Global Regulatory Submissions

Preferred Skills:

Advanced Analytics Budget Management Compliance Management Critical Thinking Data Analysis Data Privacy Standards Data Quality Data Reporting Data Savvy Data Science Data Visualization Developing Others Digital Fluency Leadership Ontology Program Management Semantic Modeling Strategic Thinking Succession Planning

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $164000 to $282900 USD.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Director