The executive will collaborate with cross-functional teams to ensure regulatory compliance for clinical supplies, devices, and related equipment, and to support submissions to regulatory authorities and ethics committees. Daily tasks include tracking regulatory changes, interpreting relevant guidelines, contributing to regulatory strategy for new and ongoing projects, and ensuring documentation is accurate, complete, and audit-ready. The role also requires close coordination with project management and operations teams to address regulatory aspects of clinical supply chain solutions and to support timely study start-up and ongoing trial conduct.

Qualifications

- Demonstrated ability to manage Regulatory Documentation and Dossier Preparation for clinical trials or medical products.





- Strong knowledge of Regulatory Requirements and Regulatory Compliance in relevant regions and global frameworks.

- Hands-on experience in Regulatory Affairs, including interaction with regulatory authorities or ethics committees.

- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.

- Understanding of clinical trial processes, GCP, and quality standards (e.g., ISO, GDPMDS) is highly beneficial.

- Excellent written and verbal communication skills, with attention to detail and solid organizational abilities.

📌 Executive, Regulatory Affairs (India)
🏢 Intrinseque Health
📍 India