Regulatory Labeling Manager

Regulatory Labeling Manager (NA and LATAM Only) 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 continuously simplify and streamline our work to make operations easier and better. Job 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. 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. Benefits The benefits for this position may include a company car or car allowance, health benefits (medical, dental, and vision), company match 401(k), eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Seniority level Entry level Employment type Full‑time Job function Legal 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 will determine what constitutes equivalent to the qualifications described. The paragraph is fully compliant with all obligations imposed by legislation in each country, including the EU Equality Directive and Americans with Disabilities Act. 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 (products that have no additional development activities ongoing). 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. Referral Information Referrals increase your chances of interviewing at Syneos Health by 2x. #J-18808-Ljbffr