Job Description

The opportunity

The Regulatory Affairs Associate III is responsible for the preparation of high-quality US Gx labeling documents filed under or associated with an ANDA and/or 505(b)2 while ensuring adherence to federal regulations and meeting deadlines driven by company goals.


Candidate will be required to work independently and possess a strong knowledge of FDA US Gx labeling regulations as well as FDA guidances to the level of applying them effectively to all work output. 

How you’ll spend your day

  • Subject Matter Expert in the development, review, and electronic compilation of labeling documents to align with the Reference Listed Drug, company goals, and submission requirements for assigned ANDAs / 505b2s 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 as well as p...

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