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: 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
- Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.
- Act as a subject matter expert for global labeling regulations, standards and best practices.
Responsibilities:
- Initiate and monitor the process for new and revised labeling requests according to internal procedures.
- Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.
- Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.
- Coordinate, monitor, and expedite labeling changes to meet established deadlines for HA submission and/or production schedules.
- Coordinating with artworks preparations team for development of label / cartons / package insert for submission purposes.
- 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.
- Monitor and update the labeling tracker to ensure timely progress and adherence to project timelines.
- Monitor global regulatory changes, guidance documents, and safety updates that impact product labeling.
- Archive controlled label copies and master label files according to internal procedures.
Required Skills and Experience
- Ability to read, understand, and follow HA regulations and guidance documents related to labeling.
- Proven experience collaborating within cross-functional teams to achieve shared objectives.
- Strong attention to detail and ability to meet deadlines
- Highly skilled at prioritizing and managing multiple tasks simultaneously.
- Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
- Strong sense of teamwork, ability to build collaborative relationships.
- Adept at identifying, addressing, and escalating issues promptly to ensure resolution.
- Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.
- Ability to work with large datasets and detailed documentation.
Preferred Qualifications
- 8-12 years of pharmaceutical labeling experience.
- Bachelor’s/ Master’s degree in scientific discipline preferred.
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.
