Regulatory Labeling Manager – Artwork Development, Source Text Review

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Review and approve labeling artwork (such as cartons, blisters, inserts, and labels) to ensure it meets regulatory compliance, readability, and aligns with the approved labeling content.

• Collaborate with teams in Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to guarantee the timely and precise development of artwork.

• Confirm that the artwork accurately reflects the approved information from prescribing information, including dosage, administration, safety warnings, and product identification.

• Provide training and oversight for additional FSP resources involved in artwork management.

• Ensure adherence to country-specific regulatory requirements, including those set by the FDA, EMA, and other global health authorities.

• Maintain thorough documentation of artwork reviews, approvals, and version control following SOPs.

• Assist in the development and upkeep of country regional text lists (cRTL).

• Review package component labeling (PCL) source text for compliance with Health Authority regulations applicable to the respective countries.

• Engage in cross-functional meetings to support product launches, labeling updates, and change control processes.

• Contribute to continuous improvement initiatives concerning artwork review processes and labeling systems.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Graphic Design, or a related discipline.

• Over 2 years of experience in pharmaceutical labeling, regulatory affairs, or artwork review.

• Strong knowledge of regulatory labeling requirements (e.g., FDA, EMA, ICH) for printed components.

• Detail-oriented with exceptional proofreading and quality control capabilities.

• Experience in annotating artwork and utilizing artwork management systems.

• Familiarity with proofreading tools (such as TVT, Global Vision).

• Capable of working independently and collaboratively in a dynamic environment.

• Excellent communication and organizational skills.

🏝️ Benefits

• We are dedicated to the growth of our employees, offering career development and advancement opportunities.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Committed to fostering an inclusive culture.