Solution Architect Pharma & Regulatory - Onsite

Solution Architect with Pharma & Regulatory Experience - Onsite

3 weeks ago Be among the first 25 applicants

• 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.

Mid-Senior level

Full-time

Other

IT Services and IT Consulting