- 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.
