Demo

Solution Architect with Pharma & Regulatory experience- Onsite

The Dignify Solutions, LLC
Raritan, NJ Full Time
POSTED ON 4/25/2025
AVAILABLE BEFORE 10/21/2025
  • 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.

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