Manager Labeling

6 days ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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 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:

  • Masters degree and 6 to 8 years of directly related experience OR
  • Bachelors degree and 8 to 10 years of directly related experience OR
  • Diploma and 10 to 12 years of directly related experience

Required 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 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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