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

Position Summary

• Senior Manager, Full Stack engineer supporting Global Regulatory Sciences (GRS) in an AI-first agile product environment.
• Accountable for end-to-end build and run of AI-native technology assets that are reliable, secure, compliant, accessible, and cost-effective.

• Own build/operation/continuous improvement of AI-native Regulatory applications and platforms (including bespoke solutions and AI-enabled SaaS).
• Ensure assets are stable, secure, compliant, and operationally sound across lifecycle; remain hands‑on to design/build/review/troubleshoot critical components.
• Develop and maintain an AI‑first Regulatory roadmap; guide build vs. buy, model selection, and platform capabilities.
• Define reference architectures, reusable patterns, and technical guardrails.
• Design and operate full‑stack cloud‑native solutions (Python, Java/Node.js, React, REST APIs) and LLM/agentic systems with monitoring, governance, and human‑in‑the‑loop.
• Build/manage ML & data pipelines (training through rollback); implement CI/CD and automate ingestion/feature engineering/versioning/deployment.
• Partner with IT Product Managers and GRS stakeholders; translate business needs into measurable regulatory/operational impact.
• Manage Total Cost of Ownership (build and run).

• 6+ years software engineering (Bio Pharma/Life Sciences strongly preferred).
• BS in CS/Software Eng/Engineering/Life Sciences or related quantitative field (advanced degree preferred).
• Proven delivery in regulated environments using Agile/structured SDLC.
• Hands‑on LLM + AI coding (e.g., Codex, Claude Code, OpenAI) and agentic/genAI (Lang Chain, Llama Index, OpenAI/AWS Bedrock).
• Python + React; familiarity with Java/Type Script/FastAPI.
• AWS (Lambda, S3, Dynamo
  
  DB, Bedrock, Sage Maker) and event‑driven microservices.
• Git/source control; SQL/No
  
  SQL data engineering; vendor/offshore experience.
• Preferred:
  Regulatory Affairs tech (Veeva RIM, Lorenz Docu Bridge, HAQ, labeling).

• Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life insurance.
• Paid Time Off (flexible time off for US exempt employees; annual paid vacation and holidays for certain roles).