Mgr Regulatory Affairs, Labeling

Job Description

As a Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals, you will be responsible for setting strategic goals, managing and leading teams, driving operational efficiency, and making high-level decisions that impact the teams success. Additionally, you will oversee the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)2s, ensuring adherence to federal regulations, internal processes, and meeting timelines driven by company goals. You will also be in charge of overseeing any/all team databases and trackers.Your key responsibilities will include:- Establishing and effectively implementing labeling strategies for all US generic product ANDAs/505(b)2s, pre and post-approval- Ensuring compliance with all required FDA reporting obligations- Providing guidance and leadership on best practices in the labeling arena- Leading daily workload activities- Developing, reviewing, and electronically compiling labeling documents to align with regulatory requirements and company initiatives- Assigning labeling projects and overseeing their progress- Maintaining labeling trackers to ensure project timelines are met- Ensuring alignment with FDA regulations and guidances, specifically in Structured Product Labeling (SPL)- Collaborating with Regulatory Operations to ensure timely project submissions following eCTD requirements- Working closely with other departments to align with the product/device strategy- Attending relevant meetings and contributing to the creation and revision of SOPs/WIs- Maintaining knowledge of US regulations, guidelines, and SOPs/WIs applicable to US Gx labeling- Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities is preferredIn terms of qualifications, we are looking for candidates with:- MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience- Minimum 8 years of US labeling experience and at least 3 years of supervisory experience preferred- Minimum 8 years of Pharmaceutical industry experience required, specifically in Regulatory Affairs & US ANDA/505(b)(2) labelingBy joining Teva Pharmaceuticals, you will be part of a global mission to make good health more affordable and accessible, impacting millions of lives around the world. If you are a detail-oriented professional with a strong background in regulatory affairs and labeling, we encourage you to apply for this exciting opportunity. As a Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals, you will be responsible for setting strategic goals, managing and leading teams, driving operational efficiency, and making high-level decisions that impact the teams success. Additionally, you will oversee the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)2s, ensuring adherence to federal regulations, internal processes, and meeting timelines driven by company goals. You will also be in charge of overseeing any/all team databases and trackers.Your key responsibilities will include:- Establishing and effectively implementing labeling strategies for all US generic product ANDAs/505(b)2s, pre and post-approval- Ensuring compliance with all required FDA reporting obligations- Providing guidance and leadership on best practices in the labeling arena- Leading daily workload activities- Developing, reviewing, and electronically compiling labeling documents to align with regulatory requirements and company initiatives- Assigning labeling projects and overseeing their progress- Maintaining labeling trackers to ensure project timelines are met- Ensuring alignment with FDA regulations and guidances, specifically in Structured Product Labeling (SPL)- Collaborating with Regulatory Operations to ensure timely project submissions following eCTD requirements- Working closely with other departments to align with the product/device strategy- Attending relevant meetings and contributing to the creation and revision of SOPs/WIs- Maintaining knowledge of US regulations, guidelines, and SOPs/WIs applicable to US Gx labeling- Experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities is preferredIn terms of qualifications, we are looking for candidates with:- MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience- Minimum 8 years of US labeling experience and at least 3 years of supervisory experience preferred- Minimum 8 years of Pharmaceutical industry experience required, specifically in Regulatory Affairs & US ANDA/505(b)(2) labelingBy joining Teva Pharmaceuticals, you will be part of a global mission to make good health more affordable and accessible, impacting millions of lives around the world. If you are a detail-oriented professiona

Keyskills :
Regulatory AffairsANDASPLRegulatory OperationsLabelingFDA RegulationsSupervisory Experience