Skip to Main Content

Job Title


Lead, Clinical Regulatory Writing & AI Solutions


Company : Asthra AI


Location : Chennai, Tamil Nadu


Created : 2025-08-01


Job Type : Full Time


Job Description

AtAsthra AI , we’re leading the charge in AI-driven automation for regulatory documents, transforming the way the pharmaceutical industry drafts and submits clinical trial-related documents. We are looking for an experiencedLead, Clinical Regulatory Writing & AI Solutionsto join our dynamic startup. If you have a strong background in drafting clinical trial documents such as protocols, CSRs, and Investigator Brochures (IB) etc., and are passionate about innovation in the regulatory space, this role is for you. Key Responsibilities:Clinical Document Drafting & Template Development:Create and refine templates for key clinical trial documents (e.g., Protocols, CSRs, IB etc.) aligned with industry standards. Prompt Engineering:Develop and enhance prompts for AI-driven document automation, ensuring they meet regulatory requirements and maintain high standards. Brand Development:Build and strengthen Asthra’s brand presence as a leader in clinical regulatory expertise. Industry Engagement:Represent Asthra AI at industry events, conduct product demos, and help position us as a trusted name in clinical regulatory writing. Ideal Candidate:Experience:5-10 years in regulatory writing, specifically focused on clinical trial-related documents (e.g., Protocols, CSRs, IB, etc.). Skill Set:Proven expertise in clinical regulatory document drafting with a keen eye for detail. Open to learning and applying prompt engineering for AI solutions. Traits:Resourceful, proactive, and collaborative. A passion for working in a fast-paced, innovative environment. Passion:Deep interest in clinical regulatory writing and AI-driven innovation for the pharma industry. Why Join Us?Startup Environment:Work in a cutting-edge startup where innovation is at the core of everything we do. Cross-functional Collaboration:Collaborate with a talented team of AI experts, engineers, and regulatory professionals to bring groundbreaking solutions to life. If you're excited about advancing clinical regulatory writing through AI and want to be part of a groundbreaking team, we want to hear from you.