Sr Data Engineering Manager

• 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:

• 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 (e.g., Databricks, AWS, Azure, or GCP).

• 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.

• Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus.

• Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments.

• Ability to translate technical capabilities into regulatory and business outcomes.Prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios.

Good-to-Have Skills:

• Prior experience working on integrated product teams or regulatory transformation programs.

• Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments.

• Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices.

Education and Professional Certifications

• 12 to 15 years of experience in Computer Science, IT or related field

• Scaled Agile SAFe certification preferred

• Project Management certifications preferred

Soft Skills:

• Excellent analytical and troub