In this vital role, you will be responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Working in close collaboration with cross-functional teamssuch as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chainyou will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards.
Key Responsibilities
Global Labeling
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Coordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuring alignment with regional and international regulations.
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Maintain and refine labeling templates, SOPs, and related documentation to sustain consistency and compliance.
Cross-Functional Collaboration
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Collaborate with local, regional, and global teamsincluding Regulatory Affairs, Quality, and Supply Chainto identify labeling requirements, address challenges, and meet project milestones.
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Communicate clearly and proactively with relevant stakeholders, providing expertise on labeling processes and compliance requirements.
Planning & Execution
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Develop detailed project plans and timelines for labeling initiatives, ensuring completion within defined schedules.
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Monitor progress, identify potential risks, and implement corrective actions to keep projects on track.
Process Improvement & Compliance
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Identify opportunities to streamline labeling workflows and enhance efficiency, driving continuous improvement within the labeling function.
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Support inspection readiness by maintaining up-to-date records, robust quality checks, and accurate documentation for audit purposes.
Technical & Operational Support
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Perform critical reviews of artwork, translations, and labeling content to verify accuracy and adherence to regulatory standards.
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Troubleshoot issues related to labeling systems, ensuring timely resolution and minimal operational disruption.
Mentoring & Knowledge Sharing
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Provide guidance and training to junior team members and new hires on labeling standards, tools, and best practices.
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Foster a culture of knowledge-sharing and continuous learning to build expertise within the team.
Qualifications
Basic Qualifications:
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Masters degree and 6 to 8 years of directly related experience OR
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Bachelors degree and 8 to 10 years of directly related experience OR
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Diploma and 10 to 12 years of directly related experience
Required Qualifications
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Knowledge of end-to-end labeling.
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Knowledge of Labeling Management Systems (e.g., Veeva Vault) and related document management tools.
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Strong knowledge of global regulatory labeling requirements, especially for pharmaceuticals or biologics.
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Proven track record in project planning and execution, with strong organizational and problem-solving skills.
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Excellent communication skills, with the ability to collaborate effectively in a global, cross-functional environment.
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Experience in continuous improvement methods to enhance labeling processes and efficiency.
Soft Skills:
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Excellent written/oral communication skills and attention to detail
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Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;
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Proficient time and project management skills.
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Self-starter with a drive and perseverance to achieve results.
