Regulatory AI Scientist, R&D & Submissions

Amneal Pharmaceuticals; Bridgewater (MA); On-site; USD 200,000 - 240,000; Full time

Job summary

Amneal Pharmaceuticals is seeking an Applied AI Scientist - R&D and Regulatory to build and deploy AI systems that speed product development and regulatory submissions. The role focuses on NLP, document intelligence, and generative AI within GxP and 21 CFR Part 11 compliance.

You will join the Enterprise AI Transformation function, collaborating with Regulatory Affairs and R&D to deliver validated, traceable AI solutions and support labeling/content generation with agentic capabilities.

Qualifications

• 5+ years developing and deploying ML/AI systems in production.
• 5+ years Python proficiency and agentic frameworks.
• 5+ years building/evaluating LLM and agentic apps incl. retrieval-augmented generation.
• 5+ years NLP on technical/scientific text including information extraction.
• 5+ years AI governance/validation in regulated environments.

Responsibilities

• Build models analyzing regulatory correspondence to identify deficiency patterns and submission risk.
• Develop retrieval and generation agentic systems over controlled scientific content with full traceability.
• Create AI-assisted drafting for product labeling with structured labeling content.
• Design evaluation frameworks and automated regression testing for generative systems.
• Validate AI systems under GxP AI framework including risk classification and qualification testing.
• Maintain production data pipelines on Databricks including OCR and entity extraction.

Skills

ML production

Python

Agentic frameworks

NLP for scientific content

AI governance & validation

Education

Bachelor's degree

Master's degree

Ph.D. (preferred)

Tools

Databricks

AWS Bedrock

SageMaker

Job description

Amneal Pharmaceuticals is seeking an Applied AI Scientist - R&D and Regulatory to build and deploy AI systems that speed product development and regulatory submissions. The role focuses on NLP, document intelligence, and generative AI within GxP and 21 CFR Part 11 compliance.

You will join the Enterprise AI Transformation function, collaborating with Regulatory Affairs and R&D to deliver validated, traceable AI solutions and support labeling/content generation with agentic capabilities.