We are looking for an experienced Regulatory Affairs skilled with robust 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 (easy 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.
📌 Regulatory Executive Nelamangala Town
🏢 Akshaya associates
📍 Nelamangala Town
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.