Talent.com
Solution Architect with Pharma & Regulatory Experience - Onsite

Solution Architect with Pharma & Regulatory Experience - Onsite

The Dignify Solutions LLCRaritan, NJ, United States
4 days ago
Job type
  • Full-time
Job description
  • Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
  • Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
  • Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
  • Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or GCP).
  • Provide thought leadership on emerging technologies (e.g., AI / ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
  • Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
  • Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
    • Create a job alert for this search

    Solution Architect • Raritan, NJ, United States