Solution Architect with Pharma & Regulatory Experience

Raritan, New Jersey

The Dignify Solutions LLC

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.

Date Posted: 04 May 2025