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5.0 - 10.0 years

4 - 8 Lacs

navi mumbai

Work from Office

Role & responsibilities Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents. Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents...

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