Senior Officer, Regulatory Operations (eCTD Publishing)

Amneal · Ahmedabad, IN

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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 cover letters, forms (356h), labeling (SPL), REMS, correspondence, and ESG submission...