Full-Time Global Labeling Operations Lead

The Global Labeling Operations Lead coordinates, manages, and executes activities for printed labeling components (packaging mock-ups, patient information leaflets, container labeling).

Key Responsibilities:

• Manage artwork projects for multiple products ensuring timely delivery.
• Coordinate labeling artwork lifecycle management with Regulatory Strategy Leads and Labeling Operations Coordinators.
• Provide regulatory expertise to cross-functional teams and vendors for printed labeling.
• Review and approve mock-ups/artworks ensuring compliance and timely delivery.
• Coordinate EU labeling readability testing and translation activities, oversee affiliate review of EU SmPC translations.
• Manage EU SmPC master documents in Veeva RIM.
• Support Global Strategic Labeling Leads in delivering submission-ready EU/US labeling documents.
• Serve as a liaison to external vendors regarding US SPL content.
• Support global labeling management improvement initiatives, developing SOPs, Work Instructions, and guidance documents.

Education/Experience:

• 5+ years experience in Labeling Operations within the pharmaceutical industry.
• Experience in developing regulatory content for printed labeling (EU/US submissions).
• Experience in global environments.
• Strong project leadership and cross-functional collaboration skills.

Skills/Knowledge:

• Strong knowledge of EU/US labeling regulations.
• Proficiency in electronic document management systems (e.g., Veeva), MS Office Suite, and Adobe Acrobat.
• Fluency in English; additional language skills are a plus.
• Strategic thinking, effective risk communication, and action recommendation skills.
• Strong attention to detail, communication, and negotiation skills.
• Comfort working across geographies/culturally diverse teams.

Personal Attributes:

• Results-driven and team-oriented.
• Excellent organizational and time management skills.
• Hands-on approach and flexibility.

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