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

Johnson & Johnson Innovative Medicine•Ambler, PA

2d•Hybrid

About The Position

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 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 https://www.jnj.com/innovative-medicine We 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 the Global Regulatory Affairs organization. This role ensures that high-value internal and external regulatory 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&J’s 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, enabling submission efficiency, enhanced compliance, and accelerated approvals. The Director, Data Products - Global Regulatory Affairs ensures Global Regulatory Affairs data is transformed into trusted, AI-ready products that accelerate submissions, enhance compliance, and provide critical regulatory insights. By embedding semantic rigor and aligning with enterprise data strategy, this role positions Global Regulatory Affairs data as a strategic asset that enables submission excellence, proactive compliance, and innovation across J&J R&D.

Requirements

PhD or Master's in informatics, computer science, life sciences, or related discipline.
8+ years of experience in pharma/biotech R&D with a focus on Global 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.
Deep knowledge of Global 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.

Nice To Haves

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

Responsibilities

Data Product Strategy & Execution Lead a team to define and deliver data products addressing critical Global Regulatory Affairs use cases (e.g., submission planning, health authority commitment tracking, labelling management, regulatory intelligence analysis).
Define and maintain a roadmap for Global 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 external Global Regulatory Affairs data sources, including health authority databases, regulatory intelligence feeds, and submission archives.
Ontology & Semantic Modelling Contribute to the development and governance of a Global Regulatory Affairs Ontology to enable semantic consistency across submission, compliance, and intelligence domains.
Align the Global Regulatory Affairs Ontology with 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 ensure Global Regulatory Affairs data products integrate seamlessly into enterprise ontologies, knowledge graphs, and catalogues.
Collaborate with Global 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, and Global Regulatory Affairs domain experts.
Establish governance models, agile delivery processes, and value-tracking metrics for Global Regulatory Affairs data products.
Value Realization & Communication Define and track KPIs to measure the impact of data products on submission timelines, compliance risk reduction, and operational efficiency.
Communicate product vision, roadmap, and value realization to Global Regulatory Affairs leadership, Data Science teams, and executive stakeholders.
Champion data literacy and adoption within the Global Regulatory Affairs organization.

Benefits

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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s 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.
https://www.careers.jnj.com/employee-benefits