Regulatory Labeling Manager
2 semanas atrás
Regulatory Labeling Manager (NA and LATAM Only) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model brings the customer and the patient to the center of everything we do, continuously simplifying and streamlining work to make us easier to work for and for our clients. Open to hiring in North America and LATAM only with no sponsorship needs. Please submit CVs in English. Job Responsibilities Review and approve labeling artwork (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 information from prescribing information—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 (FDA, EMA, ICH). Detail‑oriented with excellent proofreading and quality control skills. Familiarity with artwork management systems (GLAMS, Adobe Illustrator, Esko). Familiarity with proofreading tools (TVT, Global Vision). Ability to work independently and collaboratively in a fast‑paced environment. Strong communication and organizational skills. Benefits Possible benefits include a company car or car allowance, comprehensive health coverage (medical, dental, vision), company‑matched 401(k), participation in an Employee Stock Purchase Plan, commission/bonus opportunities, and flexible paid time off (PTO) and sick time. Eligibility varies by state or municipality; Syneos complies with all relevant paid sick‑time regulations. 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 qualifications and experience. Additional Information Tasks, duties, and responsibilities listed are not exhaustive. The Company reserves the right to assign additional tasks or responsibilities. Equivalent experience is considered. The Company complies with the Americans with Disabilities Act, providing reasonable accommodations when appropriate. This does not constitute an employment contract and does not create contractual rights. Summary The Regulatory Labeling Manager – Lifecycle Products is responsible for developing, maintaining, and overseeing labeling content for mature pharmaceutical products. The 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. #J-18808-Ljbffr
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