Regulatory AI and Content Specialist

Overview

Serve as the bridge between Pharma Development Regulatory, content management, and AI-enabled technology, driving the digital transformation of regulatory content within the PDR organization. Design, standardize, and optimize reusable regulatory content for AI-powered authoring and automation, and support the drafting of regulatory documents using AI-enabled authoring capabilities.

What you'll do

• 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.
• 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.
• Serve as a super user for the GenAI-powered platform, providing business support and user enablement.
• 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, and RDT 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.
• Work directly alongside document authors, supporting and where needed leading, the drafting of regulatory documents using AI-enabled authoring capabilities.

What you'll need

• 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.
• Good understanding of the drug development lifecycle, ICH guidelines, CTD/eCTD structure, and regulatory expectations of major health authorities, including 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.
• Excellent analytical, written communication, collaboration, and stakeholder management skills.
• A continuous learning mindset and attention to detail.

Nice to have

• Familiarity with low-code/no-code platforms.
• Experience in leading/supporting digital platform implementation, User Acceptance Testing (UAT), or business validation activities.

Details

• Location: Hyderabad.