Regulatory Labeling Manager

About This Role

The Regulatory Labeling Manager is responsible for the development, maintenance, and oversight of labeling content for pharmaceutical products. This role ensures regulatory compliance and timely artwork development for labels and packaging in North America and LATAM.

Responsibilities

• Review and approve labeling artwork for regulatory compliance, readability, and alignment with approved content.
• Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors for artwork development.
• Verify artwork reflects approved 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 (FDA, EMA, etc.).
• Maintain documentation of artwork reviews, approvals, and version control.
• Participate in cross-functional meetings to support product launches, labeling updates, and change control.
• 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
• Ability to work independently and collaboratively in a fast-paced environment
• Strong communication and organizational skills
• No sponsorship needs for North America and LATAM

Nice to Have

• Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko)
• Familiarity with proofreading tools (e.g., TVT, Global Vision)

Skills

* Required skills

Benefits