Regulatory Labeling Manager

About This Role

This role involves the development, maintenance, and oversight of labeling content for mature pharmaceutical products, ensuring regulatory compliance and timely artwork development for North American and Latin American markets.

Responsibilities

• Review and approve labeling artwork (cartons, blisters, inserts, 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.
• Train and oversee 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)
• Ability to work independently and collaboratively in a fast-paced environment
• Strong communication and organizational skills

Skills

* Required skills

Benefits