Regulatory AI & Automation Specialist

Roche Holding AG; Hyderabad; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Roche Holding AG in Hyderabad sucht einen Regulatory AI & Automation Specialist mit 4–6 Jahren Erfahrung in Software, Data Analytics oder AI/Automation. Sie arbeiten praxisnah an KI-gestützten Tools, Dokumentenverarbeitung und automatisierten Workflows zur Beschleunigung regulatorischer Abläufe.

Sie nutzen Python, SQL und Cloud-Dienste, pflegen Artefakte und treiben Agile/DevOps in einer matrixorganisation voran. Kenntnisse zu GxP/ICH-WG sind wünschenswert.

Qualifications

• 4–6 Jahre praktische Erfahrung in Softwareentwicklung, Datenanalyse oder AI/Automation
• Direkte Erfahrung in pharmazeutischer Regulatory Affairs oder klinischer Entwicklung von Vorteil
• Fortgeschrittene Generative AI-Fähigkeiten, Prompt-Architektur oder Multi-Agent-Orchestrierung
• Fortgeschrittene Programmierkenntnisse in Python und SQL für Datenextraktion, Pipelines und produktionsreifer Code
• Dokument AI & Textverarbeitung: NLP, OCR (Tesseract/AWS Textract/Azure), unstrukturiertes Dokumenten-Parsing
• Erfahrung mit REST-APIs, Git, Unit-Tests, CI/CD-Grundsätze
• Workflow-Automatisierung: Python-Orchestrierung, Low-Code-Tools (Power Automate, UiPath)
• Grundlagen Cloud-Plattformen (AWS/Azure) und Containerisierung (Docker) für Deployments

Responsibilities

• Zusammenarbeit mit Regulatory-Stakeholdern zur Bewertung von AI/Automation-Anfragen
• Bereitstellung skalierbarer KI-/ML-/Automatisierungslösungen (RPA, Low-Code, Python, NLP, Cloud-Dienste)
• Durchführung von Prozess-Mining und Opportunity-Mapping in Partnerschaft mit PDR-Teams
• Unterstützung des IT-Teams bei Betrieb und Wartung deployter Automatisierungsskripte
• Pflege technischer Artefakte und Schulung von Geschäftsbereichen
• Förderung von Agile/DevOps in Matrix-Umgebungen und Sprint-Planung
• Überwachung von Leistungskennzahlen und Bereitstellung von Einblicken an Führungskräfte
• Zusammenarbeit mit globalen Regulierungsteams zur Veranschaulichung von AI/NLP-Anwendungen

Skills

Python

SQL

NLP

RPA

DevOps

Agile

Education

Bachelor’s or Master’s in Computer Science or related

Tools

AWS

Azure

Docker

OCR

LangChain

OpenAI/AWS Bedrock

Job description

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

Role: 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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik‑Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.