Regulatory Strategy Solution Architect and Data Architect

Location: Raritan, NJ

Regulatory Strategy Solution Architect and Data Architect

Responsibilities:- Partner with Product teams, Technology Services, Data Scientists and other architects to design scalable, flexible and supportable technical systems that drive business value in support of Global Regulatory Affairs.- Develop architecture artifacts in collaboration with business and technical SMEs, data scientists, platform owners and product engineers, as well as Information Security, Quality and Technology Services stakeholders.- Create business context diagrams, process overviews, data flow diagrams, application architecture, data model overviews, integration architecture, infrastructure architecture and overviews of workflow orchestration and agentic orchestration within the solution.- Ensure architecture alignment to Regulatory, R&D and Innovative Medicine technology strategies, patterns and standards.- Enable business at scale through scalable technologies, containerized applications, multi-tenant platforms, reusable integration patterns and intelligent automation.- Capture architecture and design information and decisions using standard tools.- Architect generative and agentic solutions trained on both structured data and large document corpora in the authoring of controlled documents.

Required Skills:- BA/BS degree in a technical, engineering, data sciences or scientific field.- AWS-Certified Solutions Architect certification required.- Microsoft Azure Solutions Architect certification required.- Understanding of Pharmaceutical Regulatory Affairs domain, capabilities, data, content and terminology.- 5+ years of experience as a Solution Architect in Pharmaceutical development.- 5+ years of experience in integration design and operationalization (REST APIs, Kafka, ETL, data pipeline design, API gateways, data streaming).- 5+ years of experience working with content management platforms and structured RDBMS.- 5+ years experience architecting and deploying cloud-native, scalable solutions on AWS, GCP and/or Azure for data capture, advanced analytics and intelligent automation.- Experience architecting regulated systems (GxP, HIPAA, GDPR, etc).- Experience architecting workflow automation solutions leveraging generative AI and/or machine learning to deliver operational efficiencies.- Proficiency in frameworks such as TensorFlow, PyTorch, or similar tools for incorporating generative AI models and capabilities into agentic, workflow automation and analytic solutions.- Strong written and verbal communication skills.- Proven ability to understand and articulate business requirements, direction, and initiatives.- Excellent oral and written communication skills including the ability to translate and transform complex topics into concise architectural diagrams and presentations.- Strong ability to build and manage relationships at various levels, both inside and outside an organization.- Proven track record of designing robust, highly available, scalable and flexible solutions. Other:- 10% Travel.