Hyderabad, IND
8 hours ago
Manager _Labelling
**Job Summary** 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 teams—such as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chain—you 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** + 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:** + Doctorate degree OR + Master’s degree and 4 to 6 years of directly related experience OR + Bachelor’s degree and 6 to 8 years of directly related experience OR + Diploma and 10 to 12 years of directly related experience **Required Qualifications** + 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 detail + Ability 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
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