This role involves supporting the preparation, review, and maintenance of regulatory documentation for clinical trials and related activities. The associate will assist in compiling information for regulatory submissions, tracking approvals, and updating internal records to ensure compliance with relevant regulations and standards. Day-to-day responsibilities include monitoring regulatory requirements across regions, coordinating with cross-functional project teams, and helping identify potential regulatory or logistical risks.

The role also includes supporting audits and inspections, maintaining accurate files, and contributing to process improvements within the regulatory affairs function.

Qualifications

- Ability to manage and prepare regulatory documentation and related records, including protocols, reports, and supporting materials.
- Understanding of regulatory compliance principles and quality management standards applicable to clinical development and medical supplies.
- Knowledge of regional and international regulatory requirements relevant to clinical trials, medical devices,



and ancillary supplies.
- Experience or training in regulatory submissions processes, including compiling, formatting, and tracking dossiers and applications.
- Foundational knowledge of regulatory affairs in the biopharmaceutical, biotechnology, or clinical research workplace.
- Bachelor’s degree in life sciences, pharmacy, biotechnology, or a related discipline.
- Strong attention to detail, organizational skills, and ability to manage multiple tasks and timelines simultaneously.
- Effective written and verbal communication skills, with the ability to collaborate in cross-functional and multicultural teams.
- Proficiency with standard office software and document management tools; familiarity with quality or regulatory management systems is an advantage.
- Interest in developing a career in regulatory affairs and willingness to learn evolving global regulatory and clinical supply chain practices.

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