Senior Data Engineer

1 day ago

Hyderabad Secunderabad Telangana, India beBeeDataEngineering Full time
Data Engineering Manager Role

We are seeking a seasoned Data Engineering Manager to lead our end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting.

This role 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.

Key Responsibilities:
  • 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 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.
  • Enable integration and reporting across regulatory information management systems, 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.
Requirements:
  • 8-12 years of experience in data engineering or data architecture, with 3+ years in a senior or managerial capacity, preferably within the biotech or pharmaceutical industry.
  • Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities.
  • Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms.
  • Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD.
  • Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes.
About This Opportunity:

This is an exciting opportunity for a skilled Data Engineering Manager to join our team and contribute to the development of cutting-edge data solutions.

The successful candidate will have the opportunity to work on challenging projects, collaborate with cross-functional teams, and drive innovation in data engineering.

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