Job Description

Qualifications / Requirements

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

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- Deep knowledge of Global Regulatory Affairs processes, submission pathways (e.g., eCTD), and global health authority requirements.
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- Deep knowledge of data products, database design, and data transformation/mapping.
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- Familiarity with metadata management, ontologies, knowledge graphs, and industry standards (e.g., IDMP, xEVMPD, ICH, eCTD).
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- Strong leadership, collaboration, and communication skills; ability to translate technical strategy into business/science value.
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- Demonstrated ability to influence stakeholders and drive adoption of recent data capabilities across a complex organization.
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Other

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