The role involves supporting regulatory affairs activities, maintaining regulatory documentation, and ensuring that relevant records and submissions are accurate, complete, and up to date. The candidate will assist with preparing and reviewing regulatory documents, tracking submission timelines, maintaining compliance records, and coordinating with internal teams and external stakeholders to support regulatory requirements. The position requires solid documentation skills, attention to detail, and an understanding of applicable regulatory guidelines and procedures.

Qualification:

• Prepare, review, organize, and maintain regulatory documents and records.
• Support the preparation and submission of regulatory applications, dossiers, and supporting documentation, as applicable.
• Monitor regulatory requirements, submission deadlines, renewals, and documentation updates.
• Maintain regulatory trackers and ensure records are accurate and readily accessible.
• Coordinate with internal departments and external stakeholders to obtain required regulatory information and documents.




• Assist with reviewing product documentation and ensuring alignment with applicable regulatory guidelines.
• Support compliance activities, document control, and preparation for regulatory inspections or audits.
• Track regulatory changes and communicate relevant updates to the concerned teams.
• Follow established procedures for document management, record keeping, and regulatory reporting.
• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, or a related discipline.
• Relevant experience in Regulatory Affairs, regulatory documentation, or regulatory compliance.
• Understanding of applicable regulatory guidelines, submission procedures, and documentation requirements.
• Experience preparing, reviewing, and maintaining regulatory records and supporting documents.
• Good organizational skills and the ability to manage multiple documentation tasks and deadlines

📌 Regulatory Affairs, Operations Executive (New Delhi)
🏢 Intrinseque Health
📍 New Delhi