Software Developer Regulatory Affairs and China Clinical Development - Pharma R&D

Location: Hyderabad, India

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job description As a Software Developer, you act as a seasoned expert who takes ownership of tasks and drives quality. You will challenge the status quo, foster collaboration and mentorship, and design complex software solutions utilizing strong full-stack expertise. By possessing a deep understanding of the broader technical landscape, you will improve the entire software delivery process, proactively addressing technical debt and architectural challenges while aligning your efforts with global organizational strategies. Description of the area Job Responsibilities Scope / (Content Leadership): Takes ownership of tasks and topics that are in the "grey zone" (no defined owner), successfully driving small to medium (S/M) initiatives. Accountability/Problem Solving: Challenges the status quo and is highly skillful in navigating group dynamics and diversified settings. Fosters good collaboration, knowledge sharing, coaching, and mentoring. Stakeholder Management: Prioritizes and communicates with stakeholders effectively. Maintains a bigger picture view and understands how various technical components fit into the overall strategy and goals. Impact/Strategy: Acts as a technical mentor and aligns development plans with the global strategy. Gets involved in initiatives and tasks reaching outside of regular project scope, gives speeches, shares knowledge in organizational events (e.g., DevOps Days, Tech Talk), and engages in the organization of knowledge-sharing events. Complexity/ (Product Size): Operates at the "Product/Site" level. Business/Technical ability: Possesses a deep understanding of the broader technical landscape beyond the specific component being worked on. Formulates and implements technical strategies aligned with organizational objectives, investing time and energy into initiatives that boost creativity and innovation while keeping the highest engineering quality. Qualifications Education / Experience Bachelor's degree in Computer Science, Software Engineering, or related technical field. Having professional certifications is an advantage. 5 to 8 Years of experience in independently managing end-to-end software development tasks across various capabilities and defining solutions for moderately complex problems. Build robust systems using Python, R, FastAPI, and modern cloud architectures. You'll implement REST APIs and event-driven patterns, establish testing discipline across unit, integration, and regression suites, and maintain high code quality through Git workflows, peer review, and automated CI/CD pipelines. Design and deploy intelligent agent systems using frameworks like Strands Agents, LangChain, or AWS Bedrock. You'll master prompt engineering while understanding its limitations, implement deterministic post-processing for rule enforcement, and build RAG systems with sophisticated chunking, embedding, and re-ranking strategies. You'll evaluate models across providers (Claude, GPT), balancing cost and latency, establish comprehensive evaluation frameworks using golden datasets and LLM-as-judge approaches, and implement production-grade safety measures including guardrails, PII/PHI handling, and injection defense. Architect scalable AWS solutions leveraging Lambda, ECS Fargate, Bedrock, DynamoDB, S3, and EventBridge. You'll define infrastructure as code using Terraform, containerize applications with Docker, and build comprehensive observability through structured logging, distributed tracing, metrics, and proactive alerting. Technical Skills Strong backend and full-stack skills in Python, R, FastAPI, and modern cloud architectures. Event-Driven & Serverless Patterns. Agentic AI and LLM skills, including Agent Frameworks (Example: Strands Agents, LangChain, LangGraph, Bedrock Agents), Prompt Engineering, RAG, Vector Stores, etc. Cloud platforms & infrastructures, including AWS, Terraform, Multi-Architecture Builds, Structured Logging, Distributed Tracing, Metrics / Monitoring, etc. Proven ability to design, craft, deploy, and sustain software solutions tailored to business requirements and objectives from coding to deployments. Good understanding of cybersecurity and the implementation of secure software development practices. Ability to identify and proactively address complex technical debt, performance bottlenecks, and architectural challenges. Solid understanding of software quality management and metrics. Additional Qualifications Strong ability to plan and estimate work needed to accomplish S-M tasks. Soft skills including problem-solving, analytical thinking, communication, collaboration, and ability to work in agile environments. Extensive experience in computer system validation (CSV) that strictly complies with GxP frameworks (GCP/GMP/GVP).
Shift: CET time zone #Hyderabad 2026 Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.