Job
Description
The Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals is responsible for supervising, critically reviewing, and approving established US Gx labeling documents filed under an ANDA/505(b)(2) by team members in the US and Mumbai/Bangalore locations. The Manager must ensure compliance with federal regulations, internal processes, and company goals while meeting established timelines. Additionally, they will oversee team databases and trackers, updating them as needed. The ideal candidate should have a strong understanding of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2) and be a Subject Matter Expert in US labeling, including SPL, PADERs, and AR compilation. In this role, the Manager will be a hands-on leader, managing daily workloads, overseeing the development, review, and electronic compilation of labeling documents, ensuring alignment with FDA requirements and company goals. They will assign projects to team members, communicate and prioritize tasks, and provide training to ensure compliance with legal and regulatory requirements. The Manager will also collaborate with Regulatory Operations to ensure timely submission of projects following eCTD requirements and work closely with other departments to align with product/device strategy impacting the approved portfolio. The successful candidate will have an M.Pharm/B.Pharm with a scientific or regulatory background, or an equivalent combination of education and experience. They should have a minimum of 8+ years of US labeling experience and at least 1 year of supervisory experience, with 6 to 7 years of pharmaceutical industry experience required, specifically in Regulatory Affairs and US ANDA/505(b)(2) labeling. Experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities is preferred. Key Responsibilities: - Supervise, review, and approve US Gx labeling documents filed under an ANDA/505(b)(2) - Oversee team databases and trackers, ensuring compliance with regulations and timelines - Assign projects, communicate, and provide training to team members - Develop, review, and compile labeling documents aligning with FDA requirements and company goals - Collaborate with Regulatory Operations for timely project submissions and with other departments for product/device strategy alignment - Maintain knowledge of US regulations, guidelines, and SOPs/WIs applicable to US Gx labeling Qualifications: - M.Pharm/B.Pharm with a scientific or regulatory background - Minimum 8+ years of US labeling experience and at least 1 year of supervisory experience preferred - 6 to 7 years of pharmaceutical industry experience, specifically in Regulatory Affairs and US ANDA/505(b)(2) labeling Join Teva Pharmaceuticals in their mission to make good health more affordable and accessible worldwide by applying for the Manager Regulatory Affairs, Labeling role today.,
