4–8 years of experience in US Regulatory Affairs; hands-on experience with US ANDA submissions and eCTD; strong knowledge of USFDA regulations, labeling, and lifecycle management; effective coordination and communication skills.
Manage US ANDA filings from NPD initiation to approval; identify RLDs and review USFDA databases; coordinate with R&D, QA, QC, ADL, SCM, Medical, and PK teams; compile eCTD dossiers, SPL, and labeling; handle variations, regulatory queries, artwork compliance, and annual reports.
