The associate will support the preparation, review, and maintenance of regulatory documentation for clinical trials, ensuring compliance with relevant regulations and standards. Daily responsibilities include assisting with regulatory submissions, tracking regulatory requirements across regions, and coordinating with clinical, supply chain, and project management teams to align documentation with trial timelines. The role also involves monitoring regulatory changes, contributing to internal SOPs and quality processes, and supporting audit readiness and responses to regulatory queries.

The associate will collaborate closely with cross-functional stakeholders to help ensure that clinical studies proceed smoothly from a regulatory and operational perspective.

Qualifications

- Candidates should possess strong skills in regulatory documentation and the preparation, review, and organization of clinical trial regulatory files.
- Candidates should possess skills in regulatory compliance and understanding of applicable guidelines, standards,



and quality systems relevant to clinical development.
- Candidates should possess skills in interpreting regulatory requirements across regions and applying them to clinical study planning and execution.
- Candidates should possess skills in regulatory submissions and regulatory affairs, including compiling dossiers and supporting interactions with authorities or ethics committees.
- Relevant skills such as knowledge of GCP, clinical trial operations, and medical device or pharmaceutical regulations are beneficial.
- A bachelor’s or master’s degree in life sciences, pharmacy, biotechnology, or a related field is preferred.
- Robust written and verbal communication skills, attention to detail, and the ability to work collaboratively in cross-functional teams are required.
- Experience in regulatory or clinical affairs within the pharmaceutical, biotech, or medical device sector is an advantage.

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