Description

You will design scalable and flexible technical systems to support Regulatory Affairs functions and intelligence.

Responsibilities

• Partner with Product, Technology Services, and R&D Architecture to design systems that drive business value.
• Develop architecture artifacts including business context diagrams, data flow diagrams, application architecture, and integration architecture.
• Create data model overviews, infrastructure architecture, and Machine Learning/MLOps architectures.
• Align architecture with Regulatory, Enterprise, and R&D technology strategies, patterns, and standards.
• Capture design decisions using Lean IX, SAXpress, Draw-IO, Confluence, and MS Teams.

Required Skills

• 5+ years of experience in architecture or related technical roles.
• Deep understanding of Regulatory Affairs functions including product registrations, submission content management, label authoring, CMC, and IDMP.
• Experience with Snowflake and Denodo.
• Proficiency with NLP technologies and AWS AI/Machine Learning services.
• Hands-on experience with Calyx RIM, Veeva RIM, Docubridge, Documentum, and Docuvera.
• Knowledge of API Gateways, LLMs, graph databases, and vector databases.
• Ability to design reusable integration patterns and intelligent automation.
• Bachelor's degree or equivalent graduate level education.

Key Skills

Education

Any Gradute