Syneos Health · 19 hours ago
Regulatory Labeling Manager (NA and LATAM Only)
United States
Full-time
Remote
Mid, Senior LevelSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Regulatory Labeling Manager is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products, collaborating with internal stakeholders to ensure compliance with regulatory requirements and proper documentation of labeling decisions.
BiotechnologyHealth CarePharmaceuticalTherapeutics
No H1B
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
Qualification
Required
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
Company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase