Regulatory AI and Content Specialist
Roche
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Title - Regulatory AI and Content Specialist
Roche India - Roche Services & Solutions
Location : Hyderabad
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.
As part of Roche’s Product Development (PD), Product Development Regulatory (PDR) strengthens regulatory capabilities through scalable models and sustainable solutions that support evolving regulatory requirements, global drug development priorities, and continuous innovation, leveraging automation, AI-enabled capabilities, and emerging technologies.
The Position
As a Regulatory AI & Content Specialist, you will serve as the bridge between Pharma Development Regulatory (PDR) , content management, and AI-enabled technology, driving the digital transformation of regulatory content within the PDR organization. In this role, you will leverage your understanding of regulatory documents, content structures, and submission requirements to design, standardize, and optimize reusable regulatory content for AI-powered authoring and automation. You will play a key role in setting up, configuring and managing content use cases and templates within the in house GenAI powered platform enabling efficient, consistent, and compliant regulatory document generation for a global regulatory organization.
You will also work directly alongside document authors supporting, and where needed leading, the drafting of regulatory documents using AI-enabled authoring capabilities ensuring that what the platform produces is genuinely usable, high quality, and submission-ready.
Key Responsibilities
Regulatory Content & AI Expertise
Have a strong understanding of regulatory documents across the drug development lifecycle, including clinical, non-clinical, CMC, and CTD-based submissions.
Apply knowledge of Generative AI, structured content, and regulatory authoring principles to support AI-enabled content creation and document standardization.
Stay current with evolving regulatory requirements, AI capabilities, and industry best practices.
Regulatory Content Management & Platform Management
Analyze regulatory documents and convert them into standardized templates, reusable content components, and structured content models within the in house GenAI powered platform.
Configure and maintain templates, metadata, and content assets to enable efficient, compliant, and AI-assisted regulatory authoring.
Support content governance through template lifecycle management, version control, and content quality.
Platform Enablement & Collaboration
Serve as a super user for the GenAI powered platform, providing business support, user enablement, and contribute towards continuous improvement initiatives to enhance platform adoption and operational efficiency.
Participate in User Acceptance Testing (UAT), business validation, and release readiness activities for new platform capabilities.
Collaborate with stakeholders across PDR, PD, PT (Pharma Technical) and RDT (Roche Digital Technology) colleagues to align regulatory content with business and platform requirements.
Identify opportunities to improve regulatory content development through AI, automation, and low-code/no-code capabilities.
Who You Are
Bachelor’s or Master’s degree in Life Sciences, Pharmacology, Regulatory Affairs, or a related discipline.
4–6 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, Medical Writing, or a related pharmaceutical role.
Experience in leading/ supporting clinical or marketing authorization submissions, with a good understanding of the drug development lifecycle, ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities (e.g., FDA, EMA, MHRA, PMDA, or Health Canada).
Ability to critically review and interpret regulatory, clinical, and safety documents, and translate them into standardized, structured content for AI-enabled authoring.
Knowledge of Generative AI, AI-enabled content authoring, and digital technologies, with an interest in applying them to regulatory processes.
Experience with structured content authoring, document templating, content management, Regulatory Information Management (RIM), or AI-enabled authoring platforms; familiarity with low-code/no-code platforms is desirable.
Experience in leading/ supporting digital platform implementation, User Acceptance Testing (UAT), or business validation activities is preferred.
Excellent analytical, written communication, collaboration, and stakeholder management skills, with a continuous learning mindset and attention to detail.
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.
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