<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>Role and Responsibilities Role: Responsible for development and implementation of new and revised pharmaceutical drug product labeling for both pipeline and commercial products across global market (including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards. Key Responsibilities <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Act as a subject matter expert for global labeling regulations, standards and best practices.</li> </ul> Responsibilities: <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Initiate and monitor the process for new and revised labeling requests according to internal procedures.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.</li> <li style="font-size: 12pt; font-family: arial, helv

Deputy Manager - Labelling

Job Description