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Regulatory Affairs Associate Endo

2.0 - 6.0 years

0 Lacs

indore, madhya pradesh

On-site

The Associate, Regulatory Affairs is responsible for supporting regulatory efforts related to the submission of supplemental ANDAs, ANDA Annual Reports, Drug Listing, SPL/PLR (labeling), and other regulatory compliance matters to assist the company's approved product portfolio, both internally and externally. Key responsibilities include: - Compiling and submitting Post Approval Supplements such as PAS, CBE-0, CBE-30. - Preparing, reviewing, and submitting amendments and supplements for assigned products. - Preparing, reviewing, and submitting responses to the Agency's queries for assigned products. - Compiling and submitting Global Annual Reports. - Reviewing stability protocols and reports...

Posted 2 months ago

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