1.Prepare, compile, and review regulatory dossiers for submission in ROW/EU/CIS markets.
2.Ensure timely submission of product registration dossiers in compliance with applicable regional regulatory requirements.
3.Liaise with health authorities, partners, and internal cross-functional teams for query responses and updates.
4.Monitor changes in regulatory guidelines and proactively assess impact on product lifecycle.
5.Support renewal and variation submissions for existing products.
6.Coordinate with internal departments such as QA, QC, R&D;, and Production for required documentation.
7.Maintain regulatory databases and documentation in an organized and audit-ready manner.
8.Ensure compliance with all local and international regulatory requirements and company standards.