Posted:1 week ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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:

  • Master s degree and 6 to 8 years of directly related experience OR
  • Bachelor s 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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