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Teva Pharmaceuticals
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Regulatory Affairs Associate II, Labeling

Regulatory Affairs Associate II, Labeling

Teva Pharmaceuticals

3 - 7 years

0 Lacs

navi mumbai maharashtra

Posted:4 days ago| Platform: Shine logo

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Skills Required

regulatory affairs spl quality reviews regulatory operations business development project management pharmacy life sciences biotechnology communication skills adobe acrobat professional labeling us fda labeling regulations fda electronic submission gateway ectd requirements medical device industry organizational skills microsoft office suite

Work Mode

On-site

Job Type

Full Time

Job Description

As a Regulatory Affairs Associate II, Labeling at Teva Pharmaceuticals, you will play a crucial role in preparing and revising high-quality US Gx labeling documents for submission under an ANDA and/or 505(b)(2). Your responsibilities will include ensuring compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. You will be expected to work with minimal supervision and demonstrate a thorough understanding of US FDA labeling regulations and guidance documents. Your tasks will involve creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes. A typical day in this role will involve developing US labeling documents to align with company goals and submission requirements, proofing, editing, and formatting documents, coordinating review and approval processes, and maintaining SPL for assigned projects. You will also be responsible for preparing and compiling responses to the FDA, performing quality reviews of labeling and submission documents, and collaborating with internal and external departments to ensure project timelines are met. To excel in this position, you should have a Bachelor's or Master's degree in Pharmacy or Life Sciences with 3-5 years of experience in the pharmaceutical industry. You must possess proven experience in regulatory affairs and have a strong understanding of US FDA regulations and guidances related to US Gx labeling and drug listing. Additionally, you should be detail-oriented, have excellent communication skills, and be able to work both independently and in a team environment. Proficiency in Microsoft Office Suite, particularly in Word and Excel, as well as Adobe Acrobat Professional, is essential for this role. Familiarity with TVT is preferred. If you are looking to be part of a mission-driven team dedicated to making good health more affordable and accessible, we encourage you to apply for the Regulatory Affairs Associate II, Labeling position at Teva Pharmaceuticals.,

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Regulatory Affairs Associate II, Labeling