Regulatory AI Scientist | GxP & NLP for Health Authorities

Amneal Pharmaceuticals LLC; Bridgewater Township (NJ); On-site; USD 190,000 - 225,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an AI Scientist focused on R&D and Regulatory to develop AI systems that accelerate product development and regulatory submissions in a GxP environment.

You will build health authority content analysis models, design validation frameworks, establish data pipelines for unstructured scientific data, and present validated results to leadership, with a strong emphasis on regulatory-compliant AI governance.

Qualifications

• 5+ years of ML/AI deployment in production environments.
• Proficiency in Python, LLMs, NLP, and agentic frameworks.
• Experience validating AI in regulated environments (GxP).

Responsibilities

• Build models to analyze health authority correspondence.
• Develop retrieval and generation AI systems for regulatory content.
• Design validation frameworks.
• Execute AI validation under GxP standards.
• Establish data pipelines for unstructured scientific data.
• Measure business impact.
• Present technical validation to leadership.
• Support literature and patent mining for portfolio insights.

Skills

Python

LLMs

NLP

Agentic frameworks

AI validation

Education

Bachelor's degree in CS/Computational Chemistry/Bioinformatics

Tools

Databricks

SageMaker

Job description

Amneal Pharmaceuticals LLC is seeking an AI Scientist focused on R&D and Regulatory to develop AI systems that accelerate product development and regulatory submissions in a GxP environment.

You will build health authority content analysis models, design validation frameworks, establish data pipelines for unstructured scientific data, and present validated results to leadership, with a strong emphasis on regulatory-compliant AI governance.