Director of R&D Data Science focused on developing user-centric regulatory data products for healthcare solutions. Leading strategy to ensure AI-ready, interoperable data assets enhance compliance and submission processes.
Responsibilities
Lead the strategy, design, and delivery of user-centric data products
Ensure high-value regulatory data assets are standardized, productized, and integrated
Collaborate with Global Regulatory Affairs teams to ensure data products are AI-ready, semantically consistent, and interoperable
Define and deliver data products addressing critical Global Regulatory Affairs use cases
Develop data products through agile delivery and FAIR data principles
Contribute to the development and governance of a Global Regulatory Affairs Ontology
Partner with teams to ensure data products integrate seamlessly into enterprise ontologies
Define and track KPIs to measure the impact of data products on submission effectiveness and compliance risk reduction
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
Benefits
Medical, dental, vision insurance
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Retirement plan (pension)
401(k) savings plan
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay – 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
Job title
Director, R&D Data Science, Data Products – Global Regulatory Affairs
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