Regulatory Labeling Manager (North America & LATAM Only) – Remote
Updated: December 6, 2025
Location: USA–GA–Remote
Job ID: 25103967
About the Role
Syneos Health is seeking an experienced Regulatory Labeling Manager to support labeling governance, artwork review, and lifecycle product management across global markets. This fully remote role is open exclusively to candidates located in North America and LATAM, with no sponsorship required.
The successful candidate will provide expert oversight of labeling content for mature pharmaceutical products, ensuring alignment with global regulatory standards and supporting cross-functional teams with timely and compliant labeling updates.
Key Responsibilities
Review and approve labeling artwork including cartons, blisters, inserts, and product labels for accuracy and regulatory compliance.
Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to facilitate timely artwork updates.
Ensure artwork accurately reflects approved prescribing information (dosage instructions, administration guidelines, safety statements, product identification, and warnings).
Provide training, guidance, and oversight to additional Functional Service Provider (FSP) resources supporting artwork management.
Maintain thorough documentation of artwork reviews, approvals, and version control in compliance with internal SOPs.
Participate in cross-functional meetings supporting product launches, lifecycle labeling changes, and change control initiatives.
Ensure compliance with FDA, EMA, ICH, and other country-specific regulatory labeling requirements.
Contribute to continuous process improvements, system enhancements, and operational efficiency within labeling functions.
Required Knowledge and Skills
Strong understanding of global regulatory labeling requirements including FDA, EMA, and ICH guidelines.
Exceptional proofreading skills and attention to detail, with a strong focus on accuracy and quality assurance.
Working knowledge of artwork management systems (GLAMS, Adobe Illustrator, Esko).
Familiarity with proofreading tools such as TVT or Global Vision.
Strong communication, documentation, and organizational abilities.
Ability to work independently in a fast-paced, deadline-driven environment while effectively collaborating with global teams.
Experience Required
Minimum 5–7 years of experience in regulatory labeling, regulatory affairs, labeling operations, artwork management, or pharmaceutical lifecycle labeling.
Experience reviewing and approving labeling artwork for commercial pharmaceutical products.
Prior experience working with cross-functional teams in a regulated environment.
Experience managing version control and documentation in compliance-driven environments.
Benefits and Compensation
Syneos Health provides a comprehensive rewards program which may include:
Medical, Dental, and Vision coverage
Company car or car allowance (position-dependent)
Company-matched 401(k)
Eligibility for Employee Stock Purchase Plan
Performance-based bonus opportunities
Flexible paid time off and sick leave in accordance with local regulations
Salary Range:
Compensation varies based on qualifications, experience, and demonstrated competencies. The base range reflects the anticipated low and high values for this role.
About Syneos Health
Syneos Health is a global leader in integrated biopharmaceutical solutions, operating across 110 countries with more than 29,000 employees. The company has contributed to:
94 percent of all novel FDA-approved therapies
95 percent of EMA-authorized products
Over 200 clinical studies across 73,000 sites and 675,000+ patients
The organization is committed to fostering an inclusive workplace where employees can grow, advance, and make a measurable impact.
Role Summary
The Regulatory Labeling Manager – Lifecycle Products oversees the development and maintenance of labeling content for mature pharmaceutical products. The role includes authoring updates related to safety, regulatory changes, and internal assessments, while ensuring compliance with labeling governance procedures. The manager plays a key role in ensuring global labeling accuracy, regulatory readiness, and documentation quality.a
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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