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Regulatory Affairs Associate III, Labeling

6 - 10 years

0 Lacs

navi mumbai all india

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

regulatory affairs spl quality control proofreading project management communication skills adobe acrobat professional labeling us fda regulations drug listing fda ectd submission standards microsoft office suite structured product labeling software

Work Mode

On-site

Job Type

Full Time

Job Description

As a Regulatory Affairs Associate III at Teva Pharmaceuticals, you will be responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2). Your role will involve 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 legal and regulatory requirements. - Serve as a Subject Matter Expert (SME) in all facets of SPL/drug listing, providing guidance to team members and troubleshooting validation errors. - Work closely with the SPL Vendor and FDA Drug Listing team to resolve any drug listing issues promptly. - Prepare and compile full responses to the FDA via appropriate filing modes, including side-by-side comparisons, SPL, and other required submission materials. - Perform quality reviews of labeling and submission documents by proofreading for content accuracy. - Collaborate with external departments to align with internal product/device strategy and processes. - Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines. - Provide support to the Manager in completing the year-end FDA Mandated Blanket No Change certification. - Assist in the training of new labeling personnel. - Stay updated on US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing. Qualifications Required: - 7-9 years of experience in the Pharmaceutical Industry. - Minimum 6+ years of RA experience preferred in the respective Markets. - Bachelor's in Pharmacy/Master in Pharmacy/Master in science & Life sciences. - Ability to multitask in a fast-paced work environment. - Excellent oral and written communication skills. - Strong organizational skills with attention to detail. - Proficiency in PC and Microsoft Office Suite, including Word and Excel. - Thorough knowledge of Structured Product Labeling software. - Proficiency in Adobe Acrobat Professional. At Teva Pharmaceuticals, you will be part of a mission to make good health more affordable and accessible globally. Join our diverse team and contribute to our goal of helping millions around the world enjoy healthier lives. Apply now to be a part of our impactful journey. As a Regulatory Affairs Associate III at Teva Pharmaceuticals, you will be responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2). Your role will involve 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 legal and regulatory requirements. - Serve as a Subject Matter Expert (SME) in all facets of SPL/drug listing, providing guidance to team members and troubleshooting validation errors. - Work closely with the SPL Vendor and FDA Drug Listing team to resolve any drug listing issues promptly. - Prepare and compile full responses to the FDA via appropriate filing modes, including side-by-side comparisons, SPL, and other required submission materials. - Perform quality reviews of labeling and submission documents by proofreading for content accuracy. - Collaborate with external departments to align with internal product/device strategy and processes. - Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines. - Provide support to the Manager in completing the year-end FDA Mandated Blanket No Change certification. - Assist in the training of new labeling personnel. - Stay updated on US regulations, guidelines, and standard operating procedures applicable to US Gx labeling and drug listing. Qualifications Required: - 7-9 years of experience in the Pharmaceutical Industry. - Minimum 6+ years of RA experience preferred in the respective Markets. - Bachelor's in Pharmacy/Master in Pharmacy/Master in science & Life sciences. - Ability to multitask in a fast-paced work environment. - Excellent oral and written communication skills. - Strong organizational skills with attention to detail. - Proficiency in PC and Microsoft Office Suite, including Word and Excel. - Thorough knowledge of Structured Product Labeling software. - Proficiency in Adobe Acrobat Professional. At Teva Pharmaceuticals, you will be part of a mission to make good health more affordable and accessible globally. Join our diverse team and contribute to our goal of helping millions around the world enjoy healthier lives. Apply now to be a part of our impactful journey.

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