Regulatory Labeling Manager

Regulatory Labeling Manager (NA and LATAM Only) Join to apply for the Regulatory Labeling Manager (NA and LATAM Only) role at Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work, not only to make Syneos Health easier to work with but to make us easier to work for. 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 accelerate the delivery of therapies, because we are passionate about changing lives. Job Responsibilities Open to hiring in North America and LATAM only with no sponsorship needs. 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. 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). Detail‑oriented with excellent proofreading and quality‑control skills. Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko). 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. 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 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. Summary The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well‑documented in accordance with Labeling Procedures. Seniority Level Entry level Employment Type Full‑time Job Function Legal #J-18808-Ljbffr