Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC; Raritan (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading company is seeking a Solution Architect with Pharma and Regulatory expertise to design IT solutions for global Regulatory Affairs. This role involves developing GenAI solutions and optimizing cloud-native data pipelines while ensuring compliance with regulatory standards.

Qualifications

• Experience in Pharma and Regulatory domains.
• Expertise in designing IT solutions for Regulatory Affairs.

Responsibilities

• Lead architectural governance for regulatory systems.
• Design and optimize cloud-native data pipelines for data ingestion.

Skills

AI/ML

NLP

Cloud-native Data Pipelines

Regulatory Compliance

Tools

Azure

AWS

GCP

Job description

Solution Architect with Pharma & Regulatory Experience

We are seeking a Solution Architect with expertise in Pharma and Regulatory domains to design and implement IT solutions tailored to global Regulatory Affairs functions. This includes submissions, registration tracking, labeling, and IDMP compliance.

The role involves developing and guiding the implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. You will lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and health authority gateways.

Additionally, you will design and optimize cloud-native data pipelines for regulatory data ingestion, transformation, and analytics, utilizing platforms such as Azure, AWS, or GCP. Providing thought leadership on emerging technologies like AI/ML, LLMs, and NLP, and their relevance to regulatory landscapes, is also a key part of this role.

You will support the integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA), and work closely with Data Governance teams to ensure compliance with standards like IDMP and xEVMPD.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Other
• Industries: IT Services and IT Consulting