Global Labeling Specialist

As a key player in the regulatory submission process, you will have the opportunity to work closely with cross-functional teams to ensure compliance with global labeling requirements.

Develop and implement effective labeling strategies, collaborating with stakeholders across multiple regions and functions. Utilize your analytical skills to optimize labeling processes, improve efficiency, and enhance transparency.

• Labeling Strategy and Execution
  • Coordinate day-to-day labeling activities, ensuring timely updates and compliance with regulatory requirements.
  • Act as primary contact for cross-functional teams, offering guidance and support on labeling procedures and timelines.
  • Execute labeling change requests, tracking progress and maintaining accurate documentation in labeling management systems.
• Cross-Functional Collaboration
  • Collaborate with global and regional stakeholders to streamline labeling processes and ensure alignment across multiple time zones.
  • Identify and escalate potential compliance risks or delays, partnering with teams to resolve issues promptly.
  • Engage proactively with global affiliates to collect requirements, clarify expectations, and implement labeling changes seamlessly.
• Process Improvement and Compliance
  • Contribute to continuous improvement initiatives, optimizing labeling processes, templates, and workflows to improve efficiency and compliance.
  • Support the maintenance of inspection readiness by ensuring documentation, SOPs, and labeling processes align with quality standards and internal policies.
  • Collect and analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy.
• Stakeholder and Vendor Coordination
  • Collaborate with external vendors to ensure adherence to quality and timeline requirements.
  • Monitor vendor performance against established SLAs, promptly addressing any issues or gaps with internal teams.
  • Participate in regular meetings with internal and external stakeholders to align on project deliverables, overcome challenges, and ensure timely completion of milestones.
• Training and Knowledge Sharing
  • Provide guidance and operational support to junior staff and peers regarding labeling compliance, best practices, and quality standards.
  • Help develop or refine training materials and job aids to ensure consistent understanding and application of labeling procedures.
  • Stay updated on emerging regulatory requirements and industry trends, sharing insights to influence labeling strategies.
  Required Skills and Qualifications:
  • Doctorate degree OR Master's degree with 2 to 4 years of directly related experience OR Bachelor's degree with 4 to 6 years of directly related experience OR Diploma with 8 to 10 years of directly related experience.

Note: Equivalent combinations of education and experience will be considered.

• Experience with labeling management systems or other document management platforms.
• Familiarity with global labeling regulations and end-to-end labeling processes.
• Demonstrated ability to plan and manage projects in a matrixed environment while meeting deadlines and managing multiple priorities.
• Strong collaboration and communication skills, with experience working with international teams across different time zones.
• Proven problem-solving capabilities and an analytical mindset, with a keen attention to detail.
• Experience in vendor coordination, ensuring quality and compliance with established performance metrics.

• Opportunity to play a key role in a highly visible and impactful regulatory submission process.
• A collaborative and dynamic work environment with cross-functional and global teams.
• Competitive compensation package.
• A focus on professional growth and continuous improvement.