Job
Description
As a Regulatory Affairs Associate II at Teva Pharmaceuticals, your role involves preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2). Your responsibilities include 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 all legal and regulatory requirements. This involves QC, proofing, editing, and formatting of documents, as well as coordinating the review and approval of final submission documents. - Create compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information and adhering to compliance requirements for importation, bulk listings, and related processes. - Establish and maintain SPL for assigned projects, ensuring product data elements align with required drug listing regulations and are submitted through FDA's Electronic Submission Gateway. - Prepare and compile full responses to the FDA via the appropriate filing mode, including side-by-side comparisons, SPL, and other necessary submission materials. - Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy. - Work closely with external departments and Regulatory Operations to align with internal product/device strategy and process. - Attend project meetings to ensure labeling timelines are met and maintain an accurate project tracker for all assigned projects. Qualifications Required: - Bachelors in Pharmacy/Master in Science & Life Sciences with 4-5 years of experience in the Pharmaceutical Industry, or Master in Pharmacy with 3-4 years of experience. - Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. - Ability to multi-task in a fast-paced work environment and possess exemplary oral and written communication skills. - Organized with keen attention to detail, ability to work independently as well as in a team environment with minimal supervision. - Knowledge of US FDA regulations and guidances related to US Gx labeling, US drug listing, and eCTD submission standards. - Proficiency in PC, Microsoft Office Suite, Microsoft Word, Microsoft Excel, and Adobe Acrobat Professional. Please note that this role offers you the opportunity to work with the world's leading manufacturer of generic medicines, contributing to the mission of making good health more affordable and accessible to millions around the world. Join us in our commitment to making a difference in global healthcare. As a Regulatory Affairs Associate II at Teva Pharmaceuticals, your role involves preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2). Your responsibilities include 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 all legal and regulatory requirements. This involves QC, proofing, editing, and formatting of documents, as well as coordinating the review and approval of final submission documents. - Create compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information and adhering to compliance requirements for importation, bulk listings, and related processes. - Establish and maintain SPL for assigned projects, ensuring product data elements align with required drug listing regulations and are submitted through FDA's Electronic Submission Gateway. - Prepare and compile full responses to the FDA via the appropriate filing mode, including side-by-side comparisons, SPL, and other necessary submission materials. - Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy. - Work closely with external departments and Regulatory Operations to align with internal product/device strategy and process. - Attend project meetings to ensure labeling timelines are met and maintain an accurate project tracker for all assigned projects. Qualifications Required: - Bachelors in Pharmacy/Master in Science & Life Sciences with 4-5 years of experience in the Pharmaceutical Industry, or Master in Pharmacy with 3-4 years of experience. - Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. - Ability to multi-task in a fast-paced work environment and possess exemplary oral and written communication skills. - Organized with keen attention to detail, ability to work independently as well as in a team environment with minimal supervision. - Knowledge of US FDA regulations and guidance
