Applied AI Scientist – R&D and Regulatory

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

Role

AI Scientist in R&D and Regulatory focused on developing AI systems to accelerate product development and regulatory processes.

Responsibilities

• building models to analyze health authority correspondence
• developing retrieval and generation AI systems for scientific and regulatory content
• designing validation frameworks
• executing AI validation under GxP standards
• establishing data pipelines for unstructured scientific data
• measuring business impact
• presenting technical validation to leadership
• supporting literature and patent mining for portfolio insights

Requirements

• Bachelor's degree in Computer Science, Computational Chemistry, Bioinformatics, or related field
• 5+ years in developing and deploying machine learning or AI in production
• proficiency with Python, large language models, NLP, and agentic frameworks
• experience with AI validation in regulated environments

Preferred

• Master's or Ph.D.
• experience with Databricks and cloud ML platforms (e.g., SageMaker)
• knowledge of GxP, 21 CFR Part 11, and health authority submission content

High-Value

• focus on pharmaceutical regulatory content
• GxP compliance
• NLP over technical/scientific text
• regulated industry AI governance

Work setup

Not specified

Salary

$190K-$225K, plus performance-based incentives.