Job Description Summary

-Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides The Global Labelling Content Manager plays a supporting role in ensuring accurate, consistent, and compliant global labelling content. They contribute to the reliability and traceability of core product information, helping enable high quality labelling-quality labelling across products and markets.

 

Job Description

Key Responsibilities:

• Serve as labelling lead for assigned products, developing and maintaining compliant global labelling documents (e.g., CDS, BPL, BSS, IFU) and major market labels (USPI/PPI/MG, EU SmPC/PIL and other priority countries).
  • Organize and lead ELTF meetings to align content and comments, as appropriate for level.
  • Collaborate with Global Labelling Directors / Associate Directors to ensure aligned, compliant, and competitive labelling content across assigned tasks. Flex on projects from Director or AD GL.
  • Conduct detailed research across competitor labels, global regulations and study information to support content development.
  • Prepare documentation supporting CDS changes and contribute to responses to Health Authority queries.
  • Ensure timely country implementation of labelling changes and compliance with CDS requirements.
  • Mentor newcomers and support readiness for audits, inspections and continuous improvement initiatives.
  • Maintain appropriate document quality and traceability (version control, references and rationale) to support governance requirements and audit readiness.
  • Development and maintenance of IPLs.

Minimum Requirements:

• Typically, 2 to 5 years’ experience in Global Labelling, Regulatory Affairs, or related pharmaceutical development functions with demonstrated labelling drafting and maintenance experience.
• Working knowledge of core labelling concepts and major market formats (for example CDS, USPI, EU SmPC and PIL) and ability to apply internal standards and regulatory requirements.
• Ability to review and interpret clinical and safety information and translate into clear, consistent labelling text with appropriate referencing.
• Strong attention to detail and documentation discipline (version control, traceability, and rationale).
• Experience organizing and facilitating cross-functional meetings (for example ELTF) and managing actions to closure.
• Strong collaboration, communication, and prioritization skills; proactive issue identification and escalation.Continuous improvement mindset; experience supporting audits and inspection readiness activity
• Science-based BS or MS with demonstrated capability; advanced degree preferred

 

Skills Desired

Cross-Functional Teamwork, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety