Senior Officer, Regulatory Operations (eCTD Publishing)
Amneal
IndiaPosted about 2 months agoDiscoveredMatch locked
Full TimeAdmin Jobs
About the role
Description Having good knowledge of the regulatory guidelines related to eCTD publishing and submissions, mainly ICH M4, M8 and FDA eCTD guidances. Prepare, compile, and publish high‑quality eCTD sequences for ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines. Own Module 1 (US‑regional) requirements and ensure correct placement/metadata for
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