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Teva Pharmaceuticals
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Regulatory Affairs Associate I, Labeling

Regulatory Affairs Associate I, Labeling

Teva Pharmaceuticals

1 - 5 years

0 Lacs

navi mumbai all india

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

quality control regulatory affairs proofreading regulatory operations us fda labeling regulations structured product labeling spls fda submissions ectd requirements

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As an RA Associate I at Teva Pharmaceuticals, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations, meet deadlines, and align labeling with company goals and submission requirements. Your role will involve developing compliant Structured Product Labeling (SPL) files and maintaining knowledge of US FDA labeling regulations. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring compliance with legal and regulatory requirements. - Establish SPL for projects, ensuring alignment with required drug listing regulations. - Prepare and compile full responses to the FDA, including side-by-side comparisons, SPL, and other necessary submission materials. - Perform quality reviews of labeling and submission documents by proofreading for content accuracy. - Work with Regulatory Operations and Teva's publishing software to ensure timely submissions following eCTD requirements. - Maintain knowledge of US regulations, guidelines, and standard operating procedures related to US Gx labeling. - Collaborate effectively in a team environment and perform all job-related duties as required. Qualifications Required: - Pharma Graduate/Postgraduate with a scientific or regulatory background, or equivalent education and experience. - Bachelors in pharmacy/Masters in science & Life sciences with 2-3 years in the Pharmaceutical Industry OR Masters in pharmacy with 1-2 years in the Pharmaceutical Industry. - Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. - 1 to 3 years of pharmaceutical industry experience, specifically in Regulatory Affairs focusing on US Gx labeling. - Knowledge of SPL development and drug listing requirements. (Additional details of the company were not provided in the job description.) Role Overview: As an RA Associate I at Teva Pharmaceuticals, you will be responsible for preparing and revising high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2. You will ensure adherence to federal regulations, meet deadlines, and align labeling with company goals and submission requirements. Your role will involve developing compliant Structured Product Labeling (SPL) files and maintaining knowledge of US FDA labeling regulations. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s, ensuring compliance with legal and regulatory requirements. - Establish SPL for projects, ensuring alignment with required drug listing regulations. - Prepare and compile full responses to the FDA, including side-by-side comparisons, SPL, and other necessary submission materials. - Perform quality reviews of labeling and submission documents by proofreading for content accuracy. - Work with Regulatory Operations and Teva's publishing software to ensure timely submissions following eCTD requirements. - Maintain knowledge of US regulations, guidelines, and standard operating procedures related to US Gx labeling. - Collaborate effectively in a team environment and perform all job-related duties as required. Qualifications Required: - Pharma Graduate/Postgraduate with a scientific or regulatory background, or equivalent education and experience. - Bachelors in pharmacy/Masters in science & Life sciences with 2-3 years in the Pharmaceutical Industry OR Masters in pharmacy with 1-2 years in the Pharmaceutical Industry. - Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. - 1 to 3 years of pharmaceutical industry experience, specifically in Regulatory Affairs focusing on US Gx labeling. - Knowledge of SPL development and drug listing requirements. (Additional details of the company were not provided in the job description.)

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Regulatory Affairs Associate I, Labeling