We are looking for an experienced Regulatory Affairs skilled with strong expertise in USFDA regulations, ANDA submissions, and US regulatory requirements. The candidate will be responsible for end-to-end review and management of ANDA documentation across various dosage forms, including injectables (simple and complex) and ophthalmic products.
The role involves regulatory strategy, submission management, review of agency queries, quality change controls, DMF updates, commercial artwork approvals, and coordination with cross-functional teams to ensure timely and compliant regulatory submissions.