Manager - Labelling 04/09/2025

3 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

- 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

- 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 teamsincluding Regulatory Affairs, Quality, and Supply Chainto 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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