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Alkem Laboratories Ltd. logo
Sr. Officer - DRA US MKT Alkem Laboratories Ltd.

5.0 - 9.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a Regulatory Affairs Specialist in our company, your role will involve the following key responsibilities: - Ensuring timely response to deficiencies raised by Agency on ANDAs. - Reviewing all specifications and proposals from sites of approved ANDAs for supplement filings. - Providing regulatory support and reviewing pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control, etc. - Authoring, compiling, and reviewing ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation, and submission of the dossier. - Submitting PADER to comply with USFDA requireme...

Posted 1 week ago

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