
Leading Data Engineer for Complex Projects
1 day ago
We are seeking a Senior Data Engineering Manager to lead our 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:
- Develop and implement end-to-end regulatory operations, including data ingestion, transformation, integration, and delivery across regulatory systems.
- Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into data engineering solutions.
- Oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (e.g., eCTD, IDMP, SPL, xEVMPD).
Requirements:
- 8-12 years of experience in data engineering or data architecture, with 3+ years in a senior or managerial capacity, preferably within the industry.
- Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities.
The successful candidate will have strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments. Experience with Agile/SAFe methodologies and DevOps/DataOps best practices is also highly valued.
Benefits:
- Opportunity to work on complex data engineering projects.
- Collaborative and dynamic work environment.
- Chance to develop and implement cutting-edge data solutions.
What We Offer:
- A competitive salary and benefits package.
- Ongoing training and professional development opportunities.
- A collaborative and supportive team environment.
How to Apply:
Interested candidates should submit their resume and cover letter to us through our application portal.
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