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 a part of your role. You will be responsible for preparing Controlled Correspondence with regulatory bodies on various aspects such as Bioequivalence recommendations, Inactive ingredient levels, and Q1/Q2 sameness evaluation during early development. Additionally, you will need to file supplements for post-approval changes like PAS, CBE-30, and CBE-0. Your role will involve overseeing product lifecycle management by ensuring change control approvals and continuity through effective supplement filings. You will also be tasked with compiling Marketing Authorization Applications (MAAs) for the EU via DCP, MRP, and Centralized Procedure (Modules 15). Managing pre-ANDA meeting submissions for complex products with the USFDA will be one of your key responsibilities. You will also be expected to review Drug Master Files (DMFs), especially for complex peptides. If you feel that you are the right fit for this position, or if you know someone who might be suitable, please share your profile or connect with us at pratik.joshi@acmegenerics.in.,

Posted 1 week ago

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