Applied AI Scientist: R&D & Regulatory Solutions

Socket.dev; Bridgewater (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Amneal is seeking an Applied AI Scientist in R&D and Regulatory to advance NLP, document intelligence and generative AI for regulatory submissions, with validated systems compliant with GxP and 21 CFR Part 11.

You will build models analyzing historical health authority correspondence, develop retrieval and generation pipelines over controlled scientific content, and support drafting and comparison for labeling.

Responsibilities

• Build models that analyze historical health authority correspondence to identify deficiency patterns and flag submission risk.
• Develop retrieval and generation pipelines over controlled scientific content with full traceability.
• Enable AI-assisted drafting and comparison for product labeling, including structured labeling content.
• Design evaluation frameworks for generative systems and automate regression testing.
• Validate AI systems under GxP AI validation framework with risk classification and intended-use definitions.
• Maintain production data pipelines on Databricks over unstructured documents with OCR and entity extraction.
• Establish benefit baselines with Regulatory and R&D owners and report on cycle-time improvements.
• Present validation evidence and model limitations to Regulatory and R&D leadership.
• Educate the organization on the usage and application of agentic systems.
• Develop literature, patent, and prior-art mining capabilities to support portfolio decisions.

Job description

Amneal is seeking an Applied AI Scientist in R&D and Regulatory to advance NLP, document intelligence and generative AI for regulatory submissions, with validated systems compliant with GxP and 21 CFR Part 11.

You will build models analyzing historical health authority correspondence, develop retrieval and generation pipelines over controlled scientific content, and support drafting and comparison for labeling.