Qualifications / Requirements
Education: PhD or Master's in informatics, computer science, life sciences, or related discipline.
Experience: 8+ years in pharma/biotech R&D; focusing on Global Regulatory Affairs, regulatory operations, regulatory technology, or data product management.
Robust track record in data product development, integration, or semantic modelling in a regulated domain.
Experience with multi-modal regulatory data (submission, labelling, intelligence, compliance datasets).

Skills & Expertise
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).
Robust leadership, collaboration, and communication skills; ability to translate technical strategy into business/science value.
Demonstrated ability to influence stakeholders and drive adoption of recent data capabilities across a complex organization.

Other
Primary location: Spring House, PA (also open to Titusville, NJ).
Requires up to 25% travel.
Contract type: Fixed-term contract.
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