Regulatory Affairs US Market Injectable Immacule Lifesciences

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

We are looking for an experienced Regulatory Affairs professional with in-depth knowledge of injectable dossiers and a strong understanding of US FDA regulatory pathways. As the ideal candidate, you will have a crucial role in ensuring the successful submission and management of injectable products for regulated markets, with a focus on the United States. Your responsibilities will include compiling Abbreviated New Drug Applications (ANDAs) and Sterility Assurance Packages for ANDA filings. You will be expected to provide timely responses to ANDA deficiencies such as IRs, CRLs, and DRLs. Managing labeling compilation, including SPL files and annotated comparisons vs. RLD labels will also be ...

Posted 1 month ago

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