Assistant Manager, Regulatory Affairs - Labeling

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. 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.

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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.