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Regulatory Affairs Associate II, Labeling Teva Pharmaceuticals

3.0 - 7.0 years

0 Lacs

navi mumbai, all india

On-site

As a Regulatory Affairs Associate II at Teva Pharmaceuticals, your role involves preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2). Your responsibilities include ensuring compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. Key Responsibilities: - Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, ensuring compliance with all legal and regulatory requirements. This involves QC, proofing, editing, and formatting of documents, as well as coordinating the review and approval of final subm...

Posted 20 hours ago

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