Manager, Regulatory Affairs

Manager: Teva Pharmaceuticals USA Inc. is seeking a Manager, Regulatory Affairs (Parsippany, NJ) to prepare, review & approve regulatory submissions & guidance. Bach degree in Chem, Pharmacy, Pharmaceutics or rel. field & 3 yrs of regulatory exp w/pharmaceutical company req'd. Must have exp w/regulatory filings such as NDAs, ANDAs, INDs, Amendments & Supplements; devlpmnt of both complex & non-complex generics across a multitude of dosage forms incl combination prods; FDA & ICH guidelines; cGMP standards; Federal & State laws rel. to pharmaceutical regulatory affairs; business, scientific & personal comp sftwre apps incl TrackWise harmony for change control; & using the FDA CDER NextGen Portal for submitting FDA communications. Local telecom permitted 2 days/wk. 5% domestic travel required. Please apply at

https://careers.teva/job-invite/61105/

using Job ID 61105. Teva Pharmaceuticals USA Inc. is an EEO/AA employer. No calls.