About the Role

NKG is looking for an experienced Senior Regulatory Affairs Executive with 3+ years of relevant experience in Regulatory Affairs and regulatory consulting, preferably with exposure to Drugs/Pharmaceuticals, Diagnostics and Medical Devices.

The candidate will be responsible for independently managing regulatory projects, client requirements, regulatory submissions, approvals and compliance activities.

Key Responsibilities
• Manage end-to-end regulatory projects from initial assessment through submission, approval and post-approval activities.
• Handle regulatory requirements for Drugs/Pharmaceuticals, Diagnostics and Medical Devices.
• Review products and determine applicable regulatory pathways, classification and documentation requirements.
• Prepare, review and compile regulatory dossiers, applications and technical documentation.
• Handle product registrations, licenses, approvals, renewals, amendments, variations and post-approval changes.
• Prepare and manage responses to regulatory queries, deficiencies and clarification letters.
• Coordinate with CDSCO,



State Drug Authorities and other applicable regulatory authorities.
• Coordinate with clients, manufacturers, importers and other stakeholders for regulatory submissions and documentation.
• Provide regulatory guidance and compliance support to clients based on applicable requirements.
• Monitor regulatory updates and assess their impact on client products and ongoing projects.
• Maintain regulatory trackers, submission records, approvals and project documentation.
• Independently manage multiple projects and ensure quality and timely delivery.
• Review regulatory work prepared by junior team members and provide guidance where required.
• Participate in client discussions and support resolution of complex regulatory matters.

Required Skills & Experience
• 3+ years of relevant experience in Regulatory Affairs, preferably in a regulatory consulting environment.
• Solid hands-on experience in

📌 Senior Regulatory Affairs Executive (India)
🏢 NKG ADVISORY BUSINESS AND CONSULTING SERVICES
📍 India