Sr Data Engineering Manager

Role Description :

We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets.You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence solutions.

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 trails for regulatory data workflows, ensuring GxP and regulatory compliance.
• Guide the development of automation solutions, dashboards, and analytics that improve visibility into submission timelines, data quality, and regulatory KPIs.
• Ensure interoperability between regulatory data platforms and enterprise data lakes or lakehouses for cross-functional reporting and insights.
• Collaborate with IT, data governance, and enterprise architecture teams to ensure alignment with overall data strategy and compliance frameworks.
• Drive innovation by evaluating emerging technologies in data engineering, graph data, knowledge management, and AI for regulatory intelligence.
• Lead, mentor, and coach a small team of data engineers and analysts, fostering a culture of excellence, innovation, and delivery.
• Drive Agile and Scaled Agile (SAFe) methodologies, managing sprint backlogs, prioritization, and iterative improvements to enhance team velocity and project delivery.
• Stay up-to-date with emerging data technologies, industry trends, and best practices, ensuring the organization leverages the latest innovations in data engineering and architecture.

Must-Have Skills :

Good-to-Have Skills :

Education and Professional Certifications

Soft Skills :

Skills Required

Gcp, Power Bi, Tableau, Databricks, Azure, Aws, Data Management