The role involves preparing, reviewing, and maintaining regulatory documentation alignment with global and local regulatory standards.

The Regulatory

Affairs skilled will coordinate regulatory submissions, track approval timelines, and support interactions with regulatory authorities and ethics committees. Day-to-day tasks include monitoring regulatory requirements across different regions, assessing their impact on clinical supply chain activities, and ensuring continuous regulatory compliance for ongoing projects. The role will also collaborate closely with project management, clinical operations, and quality teams to support regulatory strategy, risk assessment, and process improvements.

Qualifications

- Candidates should possess strong skills in Regulatory Affairs and understanding of Regulatory Requirements in clinical development and medical devices.
- Candidates should possess skills in Regulatory Documentation, including preparation, review, and maintenance of dossiers and technical files.




- Candidates should possess skills in Regulatory Compliance, ensuring adherence to global and local regulations, standards, and guidelines.
- Candidates should possess skills in Regulatory Submissions, including compiling, filing, and tracking submissions to regulatory authorities and ethics committees.
- Good knowledge of clinical trial processes, medical device regulations, and global standards (e.g., ISO, GDPMDS) is beneficial.
- Strong attention to detail, analytical abilities, and organizational skills, with the capacity to manage multiple projects and deadlines.
- Effective written and verbal communication skills, with the ability to work collaboratively in cross-functional, multicultural teams.
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or a related field; prior experience in regulatory roles for clinical trials or medical devices is an advantage.

📌 Associate – Regulatory Affairs (New Delhi)
🏢 Intrinseque Health
📍 New Delhi