Regulatory Labeling Manager

About This Role

The Regulatory Labeling Manager (NA and LATAM Only) is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products that have no additional development activities ongoing. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments, ensuring compliance with country-specific regulations.

Responsibilities

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
• Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
• Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
• Provide training and oversight of additional FSP resources for artwork management.
• Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities.
• Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs.
• Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.
• Support continuous improvement initiatives related to artwork review processes and labeling systems.

Requirements

• Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH).
• Detail-oriented with excellent proofreading and quality control skills.
• Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko).
• Familiarity with proofreading tools (e.g., TVT, Global Vision).

Skills

* Required skills

Benefits