Manager, Regulatory Affairs

Description

  Pharmaceuticals Co. (Pennington, NJ) seeks Manager, Regulatory Affairs to review of patent amendment, deficiency responses, supplemental abbreviated new drug application & Annual Reports. Manage compilation, tracking & follow up with Office of Generic Drugs for submitted controlled correspondence(s) & protocol(s). Coordinate with formulation/ IRA for information request associated with controlled correspondence. Obtain review package and summary basis of approval (SBoA) packages from various agencies under FOIA as required by plant QA and product development team. Coordinate letter of authorization issuance activities for Cadila, Exemed and Exechon. Maintain track of REMS requirement & ensure its compliance with regulatory requirement. Prepare & submit Field Alert Reports to the FDA’s District Office. Salary: $117,100.00/yr. Forward resume to HRD, Zydus Pharmaceuticals USA Inc. at [email protected]