Teva Off Campus Drive for Regulatory Affairs Associate I, Labeling in Mumbai

Teva is hiring for the post of Regulatory Affairs Associate I, Labeling in Mumbai. Candidates who are looking for this opportunity can apply for this position before the last of the application. Check eligibility details and application process given below.

Company Name: Teva

Job Location: Mumbai

Job Role: Regulatory Affairs Associate I, Labeling

Experience: 1-3 year's

Employment Type: Full Time

Selection Type: Online

Educational Qualifications: Bachelor’s in pharmacy/Master’s in science & Life sciences

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Job 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.
• Establish SPL for assigned projects. Ensure product data elements align with the required drug listing regulations.
• Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary.
• Perform quality reviews of labeling and submission documents by proofreading established labeling files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT.
• Work with Regulatory Operations as well as in Teva’s publishing software to ensure assigned projects are submitted on time following the eCTD requirements related to labeling.
• Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling.
• Work in a team environment.
• Perform all other job-related duties as required by management and dictated by process changes.

Required Qualification: