Regulatory Labeling Manager - Artwork Development

at Syneos Health LLC in Chicago, Illinois, United States Job Description Regulatory Labeling Manager

• Artwork Development and Source Text Review(NA and LATAM Only) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.

We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver

• for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health
• 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.
• We are committed to building an inclusive culture
• where you can authentically be yourself. Central to this is our purpose
• Driven to Deliver
• which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities
• Open to hiring in North America and LATAM only with no sponsorship needs.
• Please submit CVs in English Labeling Manager
• Artwork Development and Source Text Review 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.

This role plays a critical part in ensuring the accuracy, clarity, and consistency of product package labeling across global markets. 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 global labeling and multilingual artwork. Knowledge of serialization, barcoding, and packaging regulations. Prior experience in a GMP-compliant environment. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to... For full info follow application link. To view full details and how to apply, please login or create a Job Seeker account