Regulatory Affairs Associate

The Senior Regulatory Affairs Associate is a tactical role within Specialty Products RA and is generally responsible for submitting routine regulatory submissions as well as working with their Supervisor on obtaining approval of regulatory submissions through interactive communication with the FDA for investigational and/or marketed drug products. Review and prepare routine (e.g., investigator submissions, correspondence to FDA, etc.) regulatory submissions as well as support senior-level staff in the preparation, QC, and submissions of major submissions (initial INDs, NDAs, sNDAs) for investigational and/or marketed drug products. Work with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issues (Senior Regulatory Associate may be afforded independence to develop initial draft for review by supervisor). Regulatory Intelligence (research regulations, guidance, precedence) responsibilities as assigned by Supervisor. Coordinate and support the team in planning and preparation for FDA meetings or teleconference. Develop and submit routine submissions to FDA and support senior-level staff with major submissions.

According to JobzMall, the average salary range for a Regulatory Affairs Associate in 145 N Brandywine St, West Chester, PA 19380, USA is between $50,000 and $90,000. This range is based on the job postings on JobzMall and the salaries reported by employers.

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).