Sr Data Engineering Manager

Roles & Responsibilities:

Functional Skills:

• Lead the engineering strategy and implementation for end-to-end regulatory operations, including data ingestion, transformation, integration, and delivery across regulatory systems.
• Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates.
• Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into data engineering solutions.
• Manage and oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (e.g., eCTD, IDMP, SPL, xEVMPD).
• Enable integration and reporting across regulatory information management systems (RIMS), EDMS, clinical trial systems, and lab data platforms.
• Implement data governance, lineage, validation, and audit trai...