Amgen
Biotech
SrDataEngineeringManager
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“Sr Data Engineering Manager at Amgen. Skills: Data Engineering Management, Regulatory Data Strategy, Data Pipeline Development, Cloud Data Platforms, GxP Compliance. Lead the engineering strategy and implementation for end-to-end regulatory operations. Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates”
Industry & Context.
Excellent analytical and troubleshooting skills
What They're Looking For.
Must Have
8–12 years of experience in data engineering or data architecture, 3+ years in a senior or managerial capacity, 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), Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes, 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
Nice to Have
Prior experience working on integrated product teams or regulatory transformation programs, Scaled Agile SAFe certification preferred, Project Management certifications preferred, Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus
What You'll Do.
Lead the engineering strategy and implementation for end-to-end regulatory operations
Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions
and lifecycle updates
Manage and oversee the development of data pipelines
and metadata frameworks
Implement data governance
and audit trails for regulatory data workflows
Guide the development of automation solutions
and coach a small team of data engineers and analysts
Drive Agile and Scaled Agile (SAFe) methodologies
managing sprint backlogs
and iterative improvements
How You'll Work.
Team & Collaboration
Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams; Collaborate with IT, data governance, and enterprise architecture teams; Ability to work effectively with global, virtual teams; Serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions
Communication Scope
verbal and written communication skills; presentation and public speaking skills; stakeholder communication
Process & Methodology
Agile methodologies, Scaled Agile (SAFe) methodologies, Sprint backlogs, Prioritization, Iterative improvements, Project management
Full Job Description
## **Career Category** Information Systems ## ## **Job Description** _ABOUT AMGEN_ Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. _ABOUT THE ROLE_ _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
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