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 www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azuritys 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. ROLE AND RESPONSIBILITIES Role: Creation and revision of pharmaceutical drug product labeling for pipeline and commercial products in compliance with FDA regulations and guidelines and reports, ensuring continued regulatory compliance. Key Accountabilities: Regulatory labeling submissions across the product lifecycle management stages in compliance with FDA regulations and labeling guidelines. Responsibilities: Initiate and monitor the process for new and revised labeling requests according to internal procedures. Preparation, compilation of labeling documents i.e., Package Insert, Medication Guide, and Annotated Comparison of Reference Listed Drug (RLD) label with proposed labeling. Preparation of Structure Product Labeling (SPL) for all the original NDA, ANDA applications, amendments, and supplements. Preparation of Drug listing SPL for NDA, ANDA applications, drug product manufacturer, private label distributors upon product approvals and RLD revisions. Monitor FDA database and DailyMed for the RLD labeling updates and initiate the revision. Ensure regulatory compliance, accuracy, and version control of all new and revised labeling. Coordinate, monitor, and expedite labeling changes to meet established deadlines for FDA submissionand/or production schedules. Initiate and approve change controls for new and revised labeling. Participate in Azurity s Labeling Management Review Committee (LMRC) weekly meetings to finalize and approve labeling. Develop collaborative and respectful relationships with internal and external customers, including but not limited to, Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and artwork and print vendors to develop labeling. Ensure product labeling complies with FDA regulations and guidelines. Archive controlled label copies and master label files according to internal procedures. QUALIFICATIONS AND EDUCATION REQUIREMENTS 8-10 years of pharmaceutical labeling experience. Bachelor s degree: degree in scientific discipline preferred. Ability to read, understand, and follow FDA regulations and guidance documents related to labeling. Experience working on cross-functional teams. PERSONAL CHARACTERISTICS Strong attention to detail and deadlines Ability to multi-task Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person) Strong sense of teamwork, ability to build collaborative relationships. Ability to recognize and escalate issues. Physical Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to sit for long periods of time While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear May occasionally climb stairs and/or ride elevators The employee must occasionally lift and/or move up to 25 pounds Employee must be able to manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required
