Regulatory Affairs Manager

The Regulatory Affairs Manager at Teva Pharmaceuticals USA, Inc. is responsible for ensuring compliance with applicable regulations and guidances by writing, reviewing, and compiling necessary documentation for submissions of ANDAs, responses to FDA deficiency letters, and post-approval supplements. This role involves assessing change controls for approved and unapproved ANDAs, training on internal SOPs, and providing regulatory strategy for R&D projects. The position allows for local telecommuting up to 2 days per week.