Applied AI Scientist – R&D and Regulatory

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

Job Description

The Applied AI Scientist - R&D and Regulatory builds and deploys AI systems that accelerate product development and regulatory submissions. The role applies natural language processing, document intelligence, and generative AI to Amneal's scientific and regulatory content, delivering validated systems that meet GxP and 21 CFR Part 11 requirements and are defensible under health authority inspection. The role sits within the Enterprise AI Transformation function, working in close partnership with Regulatory Affairs and R&D.

Essential Functions

Regulatory & Scientific Agents

• Build models that analyze historical health authority correspondence - deficiency letters, information requests, and complete response letters - to identify recurring deficiency patterns and flag submission risk prior to filing.
• Develop retrieval and generation agentic systems over controlled scientific content including specifications, analytical methods, stability data, prior filings, and eCTD, with full traceability from output to source.
• Build AI-assisted drafting and comparison capability for product labeling, including structured product labeling content and reference listed drug comparison.

AI Solution Development

• Design and maintain formal evaluation frameworks for all generative systems, including curated golden datasets, defined failure taxonomies, and automated regression testing.
• Execute AI system validation under Amneal's GxP AI validation framework: risk classification, intended-use definition, qualification testing, and periodic review.
• Build and maintain production data pipelines on Databricks over unstructured scientific documents, including OCR, parsing, and entity extraction from legacy PDF sources.

Business Impact

• Establish benefit baselines with Regulatory and R&D functional owners and measure realized cycle-time and capacity outcomes.
• Present technical approaches, validation evidence, and model limitations to Regulatory, and R&D leadership.
• Enable larger organization and educate to upskill on usage and application of agentic systems.

Research and Portfolio Insights

• Develop literature, patent, and prior-art mining capabilities supporting product development screening and portfolio prioritization.

Qualifications

Education

• Bachelor's Degree (BA/BS) Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field, with equivalent demonstrated experience (Required)
• Master's Degree (MS/MA) Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field (Preferred)
• Ph. D. Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field (Preferred)

Experience

• 5 years or more in Developing and deploying machine learning or AI systems in a production environment
• 5 years or more in Advanced proficiency with Python, agentic frameworks
• 5 years or more in Hands on experience building and evaluating LLM and agentic applications including retrieval-augmented generation, structured output, tool use, multi-step agent orchestration, and quantitative evaluation
• 5 years or more in NLP experience over technical or scientific text, including document parsing, information extraction and semantic search
• 5 years or more in AI system validation or AI governance in a regulated industry

Specialized Knowledge

• Demonstrated ability to work within documented, controlled processes and produce audit-quality technical documentation (required)
• Databricks (Unity Catalog, Delta Lake, MLflow) and cloud ML platforms such as Amazon Bedrock or SageMaker (preferred)
• Knowledge / experience with GxP-regulated environment; familiarity with 21 CFR Part 11, computerized system validation, or GAMP 5 (preferred)
• Knowledge of ANDA, NDA, or DMF submission content, eCTD structure, or health authority correspondence (preferred)

The salary range for this position ranges from $200,000 - $240,000 per year. In addition, Amneal's offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal's ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.