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.
Key Responsibilities
- 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).
Required Qualifications & Skills
- 6+ years software engineering (BioPharma/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 (LangChain, LlamaIndex, OpenAI/AWS Bedrock).
- Python + React; familiarity with Java/TypeScript/FastAPI.
- AWS (Lambda, S3, DynamoDB, Bedrock, SageMaker) and event-driven microservices.
- Git/source control; SQL/NoSQL data engineering; vendor/offshore experience.
- Preferred: Regulatory Affairs tech (Veeva RIM, Lorenz DocuBridge, HAQ, labeling).
Benefits (if applicable)
- 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).