Position Summary
The Assistant Manager – Regulatory Management will be responsible for preparing, reviewing, and submitting regulatory dossiers and applications for international markets. The role supports product registrations, renewals, variations, and regulatory compliance activities to ensure timely market access and business continuity. Key Responsibilities
Prepare and submit product registration, renewal, and variation applications in compliance with country-specific regulatory requirements and CTD/ACTD guidelines.
Coordinate with cross-functional teams to obtain, review, and compile technical documentation for regulatory submissions.
Track submission status, maintain regulatory records, and manage correspondence with health authorities.
Review and respond to regulatory queries within defined timelines.
Liaise with external regulatory partners and service providers to facilitate approvals and registrations.
Monitor regulatory changes and assess their impact o...