Regulatory AI and Content Specialist

F. Hoffmann-La Roche AG; Hyderabad; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Roche India, Roche Services & Solutions in Hyderabad, seeks a Regulatory AI and Content Specialist to lead AI-enabled regulatory content creation and platform management across the drug development lifecycle.

You will configure templates, ensure compliant content, collaborate with PDR/PD/Pharma Tech teams, and drive continuous platform improvements using AI and low-code/no-code tools.

Qualifications

• 4–6 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Writing, or related pharmaceutical role.
• Strong understanding of ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities.

Responsibilities

• Regulatory Content & AI Expertise: apply AI-enabled authoring principles to regulatory documents across the drug development lifecycle.
• Regulatory Content Management & Platform Management: convert documents into templates and structured content within the GenAI-powered platform; manage templates and content assets.

Skills

Regulatory AI

AI-enabled authoring

Stakeholder management

Education

Bachelor’s or Master’s in Life Sciences/Pharmacology/Regulatory Affairs

Tools

RIM

Low-code/no-code platforms

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 Position

The Position 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.

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.

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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.