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.