Regulatory Labeling Manager – Artwork Development and Source Text Review (LATAM Only) Updated: Yesterday Location: Tlalnepantla, MEX, Mexico Job ID: -OTHLOC-7302-2DR Job Overview This position is open to candidates located in LATAM only and does not include sponsorship. The Regulatory Labeling Manager is responsible for reviewing and approving pharmaceutical labeling artwork to ensure regulatory compliance, readability, and alignment with approved labeling content across multiple global markets. Key Responsibilities Review and approve labeling artwork (cartons, blisters, inserts, and labels) for regulatory compliance and readability. Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development. Verify that artwork reflects approved information from prescribing data, 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. Support the development and maintenance of country regional text lists (cRTL). Review package component labeling (PCL) source text for compliance with health authority regulations. 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 and Skills Strong understanding of regulatory labeling requirements (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 Bachelor’s degree in Life Sciences, Pharmacy, Graphic Design, or a related field. At least 2 years of experience in pharmaceutical labeling, regulatory affairs, or artwork review. Preferred Qualifications Experience with global 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 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. This statement is intended to comply with all obligations imposed by the legislation of each country in which the Company 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. #J-18808-Ljbffr