Senior Manager, Full Stack Engineering & Operations Regulatory BI&T

Responsibilities

• Own build, operation, and continuous improvement of AI-native Regulatory applications/platforms (bespoke + AI-enabled SaaS).
• Ensure Regulatory tech assets are stable, secure, compliant, and operationally sound.
• Remain hands‑on to design, build, review, and troubleshoot critical components.
• Develop and maintain an AI‑first Regulatory tech roadmap; guide build‑vs‑buy, model selection, and platform capabilities.
• Define and enforce reference architectures, reusable patterns, and technical guardrails.
• Design, develop, and operate scalable, secure full‑stack solutions (Python, Java/Node.js, React, REST, cloud‑native).
• Operate LLM‑native/agentic systems with human‑in‑the‑loop, monitoring, governance, and continuous improvement.
• Build and maintain ML & data pipelines (training, validation, deployment, monitoring, retraining, rollback) and CI/CD automation.
• Partner with IT Product Managers and GRS stakeholders; translate business needs into technical solutions.
• Manage total cost of ownership (build/run); ensure cost‑efficient, scalable, sustainable solutions.

• 6+ years of software engineering, with Bio Pharma/Life Sciences strongly preferred.
• Bachelor’s in CS/Software Engineering/Engineering/Life Sciences or related quantitative field (advanced degree preferred).
• Experience delivering in regulated environments using SDLC/Agile.
• Hands‑on LLM development and AI coding tools (e.g., Codex, Claude Code, OpenAI).
• Experience with generative/agentic AI systems (Lang Chain, Llama Index, enterprise LLM platforms such as OpenAI/AWS Bedrock).
• Proficiency in Python and React (Java/Type Script; FastAPI familiarity).
• Knowledge of AWS services (Lambda, S3, Dynamo
  
  DB, Bedrock, Sage Maker) and microservices/event‑driven architectures.
• Experience with Git/source control; SQL/No
  
  SQL; vendor/offshore collaboration; regulatory tech exposure (Veeva RIM, Lorenz Docu Bridge, HAQ, Labeling preferred).

• Health coverage; wellbeing support; 401(k).
• Disability, life/accident/supplemental insurance.
• Paid time off (flexible/paid holidays depending on location/employee type).

If intrigued but not a perfect match, you are encouraged to apply anyway.