This role supports regulatory activities related to clinical trials, including preparing, reviewing, and maintaining regulatory documentation and submissions in line with global and local requirements.

The Clinical

Associate collaborates with cross-functional teams to ensure compliance with applicable regulations, assists in interpreting regulatory guidelines, and helps maintain up-to-date records for audits and inspections. Day-to-day responsibilities include conducting regulatory and clinical research, tracking approvals and timelines, coordinating with clinical operations and supply chain teams, and supporting communication with regulatory authorities and ethics committees. The role also involves contributing to standard operating procedures, ensuring documentation accuracy, and supporting continuous process improvement in regulatory affairs.

Qualifications

- Strong Communication skills, including transparent written and verbal interaction with internal teams and external stakeholders.




- Proficiency in Research related to regulatory requirements, clinical guidelines, and global/local compliance standards.
- Foundational knowledge of Medicine or life sciences to understand clinical development and therapeutic areas.
- Experience or academic exposure to Clinical Trials, including protocols, ethics submissions, and regulatory documentation.
- Understanding of Healthcare systems, policies, and regulatory frameworks relevant to clinical studies.
- Bachelor’s or master’s degree in pharmacy, life sciences, medicine, regulatory affairs, or a related field.
- High attention to detail, strong organisational skills, and ability to manage multiple tasks and timelines.
- Familiarity with ISO standards and good documentation practices is an advantage.
- Prior experience in regulatory affairs, clinical research, or healthcare compliance is preferred.

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