Solution Architect with Pharma & Regulatory Experience - Onsite

The Dignify Solutions, LLC; Raritan (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading company is seeking a Solution Architect with expertise in Pharma and Regulatory domains to join their team onsite. The role involves designing IT solutions for regulatory functions, developing GenAI solutions, and leading architectural governance. The ideal candidate will have experience with cloud-native data pipelines and emerging technologies relevant to the regulatory landscape.

Qualifications

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

Responsibilities

• Architect and design IT solutions for regulatory functions.
• Develop GenAI solutions for regulatory use cases.
• Lead architectural governance for regulatory systems.

Skills

AI/ML

NLP

Cloud-native design

Tools

Azure

AWS

GCP

Job description

Solution Architect with Pharma & Regulatory Experience - Onsite

We are seeking a Solution Architect with expertise in Pharma and Regulatory domains to join our team onsite. The ideal candidate will be responsible for designing and implementing IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.

1. Architect and design IT solutions for regulatory functions.
2. Develop and guide implementation of GenAI solutions for regulatory use cases.
3. Lead architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
4. Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (Azure, AWS, GCP).
5. Provide thought leadership on emerging technologies like AI/ML, LLMs, NLP relevant to regulatory landscape.
6. Support integration of external partner systems and health authority interfaces (EMA, FDA, PMDA).
7. Collaborate with Data Governance teams to ensure compliance with IDMP and xEVMPD standards.

Senior Level

Mid-Senior level, Full-time

Job Function

Other in IT Services and IT Consulting industries.