Regulatory Labeling Manager (North America & LATAM) – Remote
Updated: December 6, 2025
Job Location: Remote – USA/Canada/Latin America
Job ID: 25103967
Company: Syneos Health
About the Role
Syneos Health is seeking an experienced Regulatory Labeling Manager to support the review, development, and governance of global labeling content for pharmaceutical products. This remote role is open exclusively to candidates based in North America or LATAM, and requires strong expertise in regulatory labeling standards, artwork approval, and cross-functional collaboration.
This position focuses on labeling content across lifecycle products, ensuring compliance with regulatory requirements while supporting efficient labeling updates, product launches, and change management processes.
Key Responsibilities
Review and approve labeling artwork, including cartons, blisters, inserts, and product labels, ensuring regulatory accuracy and alignment with approved content.
Collaborate with cross-functional teams including Regulatory Affairs, Regulatory Labeling, Packaging, Quality Assurance, and external vendors to ensure timely artwork development.
Verify artwork compliance with approved prescribing information, covering dosage, administration instructions, safety warnings, and product identification.
Provide training and oversight to Functional Service Provider (FSP) resources involved in artwork and labeling activities.
Ensure adherence to regulatory requirements across multiple regions, including FDA, EMA, and other international authorities.
Maintain thorough documentation, version control, and labeling records in accordance with internal SOPs.
Participate in cross-functional meetings to support labeling updates, product launches, and change control initiatives.
Contribute to continuous improvement activities related to labeling workflows and artwork review systems.
Required Skills and Qualifications
Strong knowledge of global regulatory labeling standards (FDA, EMA, ICH).
Excellent proofreading and quality review capabilities with high attention to detail.
Experience with artwork management platforms such as GLAMS, Adobe Illustrator, and Esko.
Familiarity with proofreading tools including TVT and Global Vision.
Ability to work independently in a high-paced, deadline-driven environment.
Strong communication, organizational, and documentation skills.
Must be able to work remotely within North America or LATAM.
CVs must be submitted in English.
Experience Required
Minimum 5+ years of experience in regulatory labeling, regulatory affairs, artwork management, or related functions within the pharmaceutical or biotechnology industry.
Experience supporting global labeling compliance for commercial or lifecycle products preferred.
Demonstrated experience working with cross-functional teams and external vendors.
Why Work with Syneos Health
Syneos Health offers a supportive environment focused on career development, technical training, leadership growth, and global engagement. Employees receive competitive benefits, which may include:
Medical, Dental, and Vision coverage
401(k) with company match
Employee Stock Purchase Plan eligibility
Performance-based bonus opportunities
Flexible paid time off and sick leave
Additional region-specific benefits
Compensation is based on experience, skills, qualifications, and applicable market conditions.
About Syneos Health
With operations in more than 110 countries and a team of over 29,000 professionals, Syneos Health is a global leader in integrated biopharmaceutical solutions. The organization has contributed to the development of the vast majority of FDA-approved and EMA-authorized therapies over the past five years.
Syneos Health fosters a culture where employees can grow, innovate, and make a meaningful impact.
Summary
The Regulatory Labeling Manager – Lifecycle Products is responsible for maintaining, developing, and overseeing labeling content for mature pharmaceutical products. This includes authoring updates based on safety changes, regulatory requirements, and internal assessments. The role ensures alignment with established labeling procedures and governance processes.
Gujarat :
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