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Regulatory Affairs Associate III Teva Pharmaceuticals

6.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a Labeling Specialist in the Pharmaceutical Industry, you will be responsible for developing US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s. Your role will involve ensuring that labeling meets all legal and regulatory requirements through QC, proofing, editing, and formatting of documents. You will coordinate the review and approval of final submission documents with all relevant departments. Your expertise will be crucial in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities. Serving as a Subject Matter Expert (SME) in SPL/drug listing, you will provide gu...

Posted 2 months ago

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