Manager, Regulatory Affairs

<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 <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 a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. Key accountabilities include providing regulatory guidance, requirements and strategy for assigned projects, ensuring compliance with regulations, company standards and commitments. The regulatory team works across multiple complex projects, facilitating various types of submissions to agencies like the FDA, HC, EMA, MHRA and other international authorities, by ensuring compliance with evolving regulations.</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;">Represent Regulatory Affairs on assigned product and related project team (both internal and external cross-functional teams)</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory assessment of 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;">Serve as primary interface with FDA and other health authorities and regulatory agencies for assigned products.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Drive regulatory strategies for drug product registration and life-cycle management across global markets, with primary responsibility of managing submissions within North America.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage regulatory filings including IND, NDA, ANDA and NDS for a