Regulatory Labeling Manager – NA, LATAM

Yesterday

🌵 Arizona – Remote

Although this job is listed in Arizona, this company may be open to hiring remote in other states.

🦞 Maine – Remote

Although this job is listed in Maine, this company may be open to hiring remote in other states.

+3 more states

🌵 Arizona – Remote 🦞 Maine – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote ⚓ Rhode Island – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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

🎯 Requirements

• 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