Regulatory Labeling Manager – Artwork Development And Source Text Review (Latam Only) (Bogotá)

Position Summary

The Labeling Artwork Reviewer is responsible for the review and approval of pharmaceutical labeling artwork to ensure compliance with regulatory requirements, internal standards, and market‑specific guidelines.

Key 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.

Required Knowledge/Skills

• 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.

Required Experience and Education Level

• 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.

Preferred Qualifications

• Experience with general labeling and multilingual artwork.
• Knowledge of serialization, barcoding, and packaging regulations.
• Prior experience in a GMP‑compliant environment.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Equal Employment Opportunity Statement

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Location: Bogota, DC, Colombia