Manager _Labelling
Amgen
**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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