Consultant – Clinical Trials, Global Regulatory Application Specialist for AI Application

Job Title:

Location:

About Us

Dizzaroo Private Limited is developing an AI-powered application to streamline and accelerate the global clinical trial application process. Our platform is designed to simplify the preparation, submission, and tracking of regulatory packages worldwide.

Role Overview

We are seeking a domain expert with hands-on experience in global clinical trial regulatory submissions to guide the design and structure of our regulatory application packages. This is a consulting role where your expertise will help ensure our AI-driven solution meets the highest industry standards and regulatory expectations.

Key Responsibilities

• Provide strategic and technical input on the design of global clinical trial application packages
• Advise on country-specific requirements for clinical trial applications
• Collaborate with our product and AI development teams to ensure regulatory accuracy and compliance
• Share best practices for document management, indexing, and submission workflows
• Offer insights into integration with regulatory systems and health authority portals
• Support identification of trial master file (TMF) content requirements for inclusion in the platform

Qualifications

• Strong background in global clinical trial regulatory submissions (IND, CTA, IMPD, etc.)
• Experience preparing submission-ready documents in line with ICH, EMA, FDA, and other country-specific guidelines
• Trial Master File (TMF) experience is a plus
• Familiarity with electronic submission standards (eCTD, country-specific formats) preferred
• Ability to work closely with cross-functional and technical teams

Why Join Us?

• Shape a first-of-its-kind AI platform in the regulatory space
• Flexible consulting arrangement — work from anywhere
• Collaborate with a passionate, innovation-driven team

How to Apply:

Send your resume/CV and a short note on your relevant experience to dhirajg@dizzaroo.com or apply directly here on LinkedIn.