Regulatory Labeling Manager – Artwork Development, Source Text Review
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Job Description
Labeling Artwork Reviewer ensuring compliance in pharmaceutical product packaging through detailed review and collaboration with various teams. Focused on regulatory requirements and global market alignment.
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.
- 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.
- Support the development and maintenance of country regional text lists (cRTL).
- Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries.
- 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:
- Bachelor’s degree in Life Sciences, Pharmacy, Graphic Design, or a related field
- 2+ years of experience in pharmaceutical labeling, regulatory affairs, or artwork review
- Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH) for printed components
- Detail-oriented with excellent proofreading and quality control skills
- Experience with annotation of artwork and working in artwork management systems
- 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.
Benefits:
- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Committed to building an inclusive culture
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