Manager Regulatory Affairs

Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. Prepare, review and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance. Assess risks throughout R&D, filing, deficiency rounds and post-approval and documents these risks appropriately. Escalates project issues and risks to management appropriately. Leads preparation meetings for FDA. For example, leads in defining questions and all supporting information for Pre-ANDA meeting with FDA for complex projects. Implements policies to assure on-going compliance of Regulatory Affairs activities. Interacts with the FDA to facilitate approval of the regulatory submissions.

According to JobzMall, the average salary range for a Manager Regulatory Affairs in 4710 Wiley Post Way, Salt Lake City, UT 84116, USA is $87,000 to $108,000 per year. This range can vary depending on the employer, the industry, the experience level, and the qualifications of the candidate.

Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S. Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC).