Manager, Regulatory Affairs
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About The Position
Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to evaluate Change Requests/Change Controls and provide accurate regulatory assessments for changes impacting applications in development such as INDs and CTAs, submitted but not yet approved applications, and approved BLA applications. The role involves assisting to upkeep regulatory tools like standard procedures, authoring guides, position papers, and templates, as well as communicating Health Authority communication to SMEs within the organization and archiving communication per standard practice. The manager will review guidance's and regulations for regions within the scope of assigned projects, train on internal SOPs and Work Instructions, and create and utilize job aids and reviewing tools as required. Additionally, the manager will assist in compiling, authoring, and reviewing applications such as INDs, IMPDs, and BLAs, associated unsolicited pre-approval changes, post-approval changes, and address requests for information. The position requires performing evaluation of change in conjunction with previous health authority feedback and current guidance and regulations, assisting in communicating regulatory strategy to SMEs for applications, and aiding in knowledge sharing and matrix training of new employees or new skills. Local telecommuting is permitted up to 2 days per week, with 5% domestic travel and 5% international travel required.
