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. You must demonstrate the ability to work independently, possess a strong knowledge of US FDA labeling regulations and guidance documents, and create compliant Structured Product Labeling (SPL) files. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s to meet legal and regulatory requirements, including QC, proofing, editing, and formatting. - Serve as a Subject Matter Expert (SME) in SPL/drug listing and provide guidance to team members on established SPL documents. - Work closely with external departments and FDA Drug Listing team to resolve drug listing issues. - Prepare and compile full responses to the FDA, including side-by-side comparisons, SPL, and other submission materials. - Perform quality reviews of labeling and submission documents, ensuring content accuracy. - Maintain an accurate project tracker of assigned projects with identified due date priorities. - Support products falling under Business Development deals and attend project meetings to ensure labeling timelines are met. - Assist in the training of new labeling personnel and stay updated on US regulations, guidelines, and standard operating procedures. Qualifications Required: - 7-9 years experience in the Pharmaceutical Industry. - Min 6+ years of RA experience preferred in respective Markets. - Bachelors in Pharmacy/Master in Pharmacy/Master in science & Life sciences. - Ability to multitask in a fast-paced environment with exemplary communication skills. - Organized with attention to detail, project management skills, and ability to collaborate effectively with cross-functional teams. - Proficiency with PC and Microsoft Office Suite, including Microsoft Word and Excel. - Thorough knowledge of Structured Product Labeling software and proficiency in Adobe Acrobat Professional. Please note that as a Regulatory Affairs Associate III at Teva Pharmaceuticals, you will play a crucial role in ensuring compliance with FDA regulations, contributing to the company's mission of making good health more affordable and accessible. Apply now to be part of a global team dedicated to improving the lives of millions worldwide. 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. You must demonstrate the ability to work independently, possess a strong knowledge of US FDA labeling regulations and guidance documents, and create compliant Structured Product Labeling (SPL) files. Key Responsibilities: - Develop US labeling documents for assigned ANDAs and/or 505(b)(2)s to meet legal and regulatory requirements, including QC, proofing, editing, and formatting. - Serve as a Subject Matter Expert (SME) in SPL/drug listing and provide guidance to team members on established SPL documents. - Work closely with external departments and FDA Drug Listing team to resolve drug listing issues. - Prepare and compile full responses to the FDA, including side-by-side comparisons, SPL, and other submission materials. - Perform quality reviews of labeling and submission documents, ensuring content accuracy. - Maintain an accurate project tracker of assigned projects with identified due date priorities. - Support products falling under Business Development deals and attend project meetings to ensure labeling timelines are met. - Assist in the training of new labeling personnel and stay updated on US regulations, guidelines, and standard operating procedures. Qualifications Required: - 7-9 years experience in the Pharmaceutical Industry. - Min 6+ years of RA experience preferred in respective Markets. - Bachelors in Pharmacy/Master in Pharmacy/Master in science & Life sciences. - Ability to multitask in a fast-paced environment with exemplary communication skills. - Organized with attention to detail, project management skills, and ability to collaborate effectively with cross-functional teams. - Proficiency with PC and Microsoft Office Suite, including Microsoft Word and Excel. - Thorough knowledge of Structured Product Labeling software and proficiency in Adobe Acrobat Professional. Please note that as a Regulatory Affairs Associate III at Teva Pharmaceuticals, you will play a crucial role in ensuring compliance with FDA regulations, contributing to the company's mission of making good health more affordable and accessible. Apply now to be part of a global tea
