Regulatory AI & Automation Specialist

Job description

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 PositionRole: Regulatory AI & Automation Specialist Location: Hyderabad Job Type: Full Time Years of Experience: 4–6 years A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. Mission Roche Services & Solutions (RSS) aims at "transforming the way Roche operates.'' As a global organization of over 3,500 colleagues, we enable Roche to operate in a competitive and ever-changing business environment. We provide our partners with end-to-end business services and solutions, enabling them to focus on patient-centric activities. Embracing an OneRoche mindset, we leverage our global network located in Budapest (Hungary), Riga (Latvia), Chennai & Hyderabad (India), San José (Costa Rica), Kuala Lumpur (Malaysia), and our other sites to remain customer-centric 24/7 and co-create solutions together. The PD Regulatory Innovation and Sustainment Chapter is accountable for creating and maintaining a framework for building, maturing, and sustaining PDR business capabilities. This includes fostering innovation, ensuring operational readiness, and implementing continuous improvement across our regulatory processes, systems, and tools. Chapter members lead by designing and deploying innovative, compliant solutions that optimize regulatory workflows while maintaining the highest standards of integrity and data quality. We operate with enterprise thinking in a highly transformative regulated environment—assessing end-to-end processes, anticipating regulatory landscape changes, and unlocking company-wide benefits through strategic partnerships across PD, affiliates, Pharma, and the Roche group. Success in this chapter requires strategic thinking, systems thinking, data and content management expertise, an enterprise mindset, and the ability to drive continuous improvement and change leadership in a matrix environment. Your Opportunity As a Regulatory AI & Automation Specialist within PD Regulatory Innovation and Sustainment Chapter at RSS Hyderabad, you will drive the hands-on digital execution of regulatory operations. In this role, you will design, build, and deploy AI-driven tools, document intelligence engines, and automated workflows that accelerate regulatory document processing, submission dossier management, and compliance tracking across global health authorities Key Responsibilities: Collaborate with regulatory stakeholders to evaluate incoming AI/automation requests, assess technical feasibility, and help prioritize high-value use cases for regulatory document workflows. Build and deploy scalable AI, machine learning, and automation solutions—integrating RPA, Low-Code/No-Code platforms, Python, NLP, and cloud-native services like AWS—specifically tailored to optimize global regulatory workflows and document management. Perform operational process mining and opportunity mapping by partnering directly with SMEs from PDR Innovation & Sustainment chapter and global regulatory SMEs to identify high-impact AI and automation opportunities. Support IT team by providing business directions for ongoing technical & preventive maintenance, performance monitoring, and troubleshooting for all deployed automation scripts, machine learning models, and AI assets operating in production. Maintain comprehensive technical artifacts (including solution architecture, source code repositories, and testing frameworks) and conduct hands-on internal training to empower business teams and drive adoption across global regulatory functions. Drive cross-functional Agile and DevOps execution in a matrixed environment, collaborating with PDR Innovation & Sustainment chapter leads, regulatory teams, IT, and RSS peers through sprint planning, rapid PoC prototyping, iterative testing, and continuous feedback loops. Monitor operational performance metrics and deliver clear project updates, technical insights, and continuous improvement recommendations to functional leadership and regulatory stakeholders. Partner with global regulatory teams to showcase the practical applications of AI, NLP, and automation, translating technical features into clear business benefits like compliance risk reduction, improved document processing throughput, and operational efficiency. Who You Are You are a hands-on technical builder with 4–6 years of experience in software engineering, data analytics, or AI/automation development and exposure of working in pharmaceutical R&D regulatory affairs or clinical development departments. You possess strong analytical problem-solving skills and thrive in an agile setting where you take ownership of technical execution, turning complex operational processes into automated, production-ready AI tools. Qualifications & Technical Skillset: Education & Experience: Bachelor’s or Master’s in Computer Science, Data Science, Information Technology, Statistics, or a related quantitative field, with 4–6 years of hands-on experience building and deploying software, automation, or AI/ML solutions Education & Experience: Direct experience in pharmaceutical R&D regulatory affairs or clinical development. Advanced GenAI: Experience exposure to prompt evaluation frameworks, or multi-agent orchestration. Core Programming & Data Engineering: Advanced proficiency in Python and SQL for data extraction, manipulation, pipeline creation, and writing modular, production-ready code. Document AI & Text Processing: Practical experience with Natural Language Processing (NLP), Optical Character Recognition (OCR like Tesseract, AWS Textract, or Azure AI Document Intelligence), and unstructured document parsing (PDFs, XML, JSON, Word). AI & LLM Integration: Hands-on experience developing application logic around modern LLM frameworks (e.g., Lang Chain, Llama Index, OpenAI/AWS Bedrock APIs) and building Retrieval-Augmented Generation (RAG) pipelines for document querying. Software Engineering & APIs: Solid experience with REST APIs, Git version control, unit testing, and basic CI/CD practices. Workflow & Process Automation: Experience automating workflows using Python orchestration, low-code automation tools (e.g., Power Automate, UiPath), or enterprise schedulers. Exposure to Deployment & Cloud: Basic exposure to cloud platforms (AWS, Azure) and containerization (Docker) for deploying scripts and API services. Strong to have: Prompt Architecture & Validation: Ability to design complex, multi-step prompts; validate outputs against business logic; and refine solutions iteratively. Regulatory Domain Knowledge: Foundational knowledge of ICH guidelines FDA/EMA submission processes, regulatory document formats (eCTD, GxP guidelines, CT documentation), emerging AI/ML regulatory guidance. Note: This job description is intended as a general guideline for the responsibilities and qualifications required for this position. It is not an exhaustive list, and responsibilities may evolve and change based on business needs. Who we areA 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