Regulatory Affairs Associate/Senior Associate

<div class="content-intro"><p><span style="font-family: Arial; font-size: 12pt;">Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit&nbsp;<a href="http://www.azurity.com/">www.azurity.com</a>.</span></p> <p><span style="font-family: Arial; font-size: 12pt;">Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.</span></p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Brief team/department description:</strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.&nbsp; The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Principle Responsibilities:</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory assistance with due diligence requests to support new business development activities.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support interaction with FDA and other regu