Regulatory AI and Content Specialist

Roche Holding AG; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Roche Holding AG, via Roche India – Roche Services & Solutions à Hyderabad, recherche un Régulatory AI & Content Specialist. Vous reliez le développement réglementaire et le contenu avec une plateforme GenAI interne, pour garantir des résultats conformes et prêts à la soumission.

Vous exploitez les documents réglementaires, standardisez les contenus et collaborez avec les équipes PDR, PD, PT et RDT pour améliorer l’efficacité et l’utilisation de l’IA dans les processus de rédaction.

Qualifications

• Bachelor ou Master dans les domaines pertinents (Life Sciences, Pharmacology, Regulatory Affairs).
• Expérience 4–6 ans en Regulatory Affairs, Regulatory Operations, Regulatory Writing ou Medical Writing.
• Connaissance des documents réglementaires et du cycle de développement des médicaments.

Responsibilities

• Comprendre les documents réglementaires tout au long du cycle de développement (cliniques, non cliniques, CMC, CTD).
• Appliquer l’IA générative et les contenus structurés pour l’édition réglementaire et la standardisation des documents.
• Rester informé des évolutions réglementaires et des capacités d’IA et des meilleures pratiques.
• Analyser les documents et les convertir en modèles standardisés et composants réutilisables dans la plateforme GenAI interne.
• Configurer et maintenir les templates, métadonnées et actifs de contenu pour un autoring IA-friendly et conforme.
• Participer à la gouvernance du contenu via gestion du cycle de vie des templates et contrôle de version.
• Collaborer avec les équipes PDR, PD, PT et RDT pour aligner le contenu avec les exigences métier et plateforme.
• Identifier des opportunités d’amélioration via IA, automatisation et low-code/no-code.

Skills

Expérience en réglementation

IA/AI générative pour contenu

Education

Bachelor ou Master en Sciences de la vie ou Réglementaire

Job description

Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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.

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