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