Manager Regulatory Affairs
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About The Position
Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager based in Parsippany, NJ. This role is pivotal in ensuring compliance with applicable regulations and guidance by writing, reviewing, and compiling documentation and data necessary for submissions of assigned Abbreviated New Drug Applications (ANDAs), responses to FDA deficiency letters, correspondences, and post-approval supplements. The position requires limited supervision from the manager, allowing for a degree of autonomy in decision-making and regulatory assessments. The Regulatory Affairs Manager will also assess change controls for both approved and unapproved ANDAs, making appropriate regulatory determinations based on the latest FDA regulations and guidance. In addition to the core responsibilities, the Regulatory Affairs Manager will be responsible for training on internal Standard Operating Procedures (SOPs) and requirements as applicable. The role involves providing regulatory strategy for assigned Research and Development (R&D) projects, ensuring alignment with agency requirements among project stakeholders. The position allows for local telecommuting, permitting up to two days per week, which offers flexibility in work arrangements. The successful candidate will be part of a mission-driven organization that aims to make good health more affordable and accessible, contributing to the health of millions around the world. Teva Pharmaceuticals is recognized as a leading manufacturer of generic medicines and is committed to continuous improvement and innovation in the pharmaceutical industry.
