<div class="content-intro">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>. 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.</div>Brief team/department description: 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. Project may support developmental product activities as well as the life-cycle management of commercial products. Responsibilities include providing regulatory guidance, determining requirements and strategy for assigned projects, authoring Health Authority (HA) submissions for US and for Canada, and ensuring compliance with regulations, company standards and commitments. Principle Responsibilities: <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Represent Regulatory Affairs on assigned product and related project teams (both internal and external cross-functional teams)</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provide regulatory assessment of due diligence requests to support new business development activities.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Serve as primary interface with FDA and Health Canada for assigned products. Prepare and author portions of Health Authority meeting request and briefing documents. Attend Health Authority meetings as assigned.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Drive regulatory strategies for drug product registration and for life-cycle management across North America.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage regulatory f

Senior Manager, Regulatory Affairs

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