Posted:1 day ago|
Platform:
Work from Office
Full Time
Candidate should be well-versed with Regulatory guidelines, US-FDA, Health Canada, EMA
Compilation, review and submission of ANDA, Controlled correspondences, Scientific package to USFDA and responding to queries.
Suggest regulatory pathway during development phase for ANDAs.
Handling of product life cycle changes and guide cross functional team for filing strategy
Review of DMFs., PDR, Labelling and other product related documentation for ANDA.
Establishment registration, re-registration, and submitting annual updates
Sentiss Pharma
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