This role is responsible for supporting regulatory activities related to global clinical development, including preparing, reviewing, and maintaining regulatory documentation in line with applicable standards. The associate will help interpret and apply regulatory requirements, support the preparation and coordination of regulatory submissions, and assist in ensuring ongoing regulatory compliance across projects and regions. Day-to-day tasks include collaborating with cross-functional teams (such as project management, quality, and clinical supply chain), tracking regulatory changes, maintaining internal records and databases, and contributing to standard operating procedures. The position also involves communicating clearly with internal stakeholders and clients regarding regulatory timelines, expectations, and deliverables. Qualifications
• Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions, including drafting, compiling,



and reviewing clinical trial-related regulatory materials.
• Candidates should possess solid knowledge of Regulatory Compliance and Regulatory Requirements, with the ability to interpret guidelines and ensure adherence to relevant national and international regulations.
• Candidates should possess foundational expertise in Regulatory Affairs, with a demonstrated interest in clinical development and medical device or biopharmaceutical regulation.
• Candidates should possess robust attention to detail, organizational skills, and the ability to manage multiple projects and deadlines in a fast-paced environment.
• Candidates should possess effective written and verbal communication skills, with the ability to work collaboratively in cross-functional teams and interact professionally with clients and regulatory bodies.

📌 Regulatory Affairs Associate (India)
🏢 Intrinseque Health
📍 India