Data Engineering Manager

Role Description:

We are seeking a SeniorData EngineeringManager 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, ensuringtimelyandaccuratedelivery 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:

• 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 troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills