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Regulatory Labeling Manager (Na And Latam Only)

Syneos Health
Syneos Health
4-7 years
Not Disclosed
10 Dec. 11, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Regulatory Labeling Manager (North America and LATAM Only)

Location: Remote (USA – AL)
Job ID: 25103967
Updated: December 6, 2025
Status: This job posting is no longer active

Position Overview

The Regulatory Labeling Manager is responsible for managing, reviewing, and maintaining labeling content and artwork for pharmaceutical products across North America and LATAM. This role supports global compliance requirements and ensures all labeling materials meet FDA, EMA, ICH, and regional health authority standards. The position requires strong cross-functional collaboration and detailed oversight of lifecycle labeling activities for mature products.

This role is open exclusively to candidates based in North America and LATAM. Sponsorship is not available.

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical, medical, and commercial success for global clients. With a presence in 110 countries and more than 29,000 employees, the company focuses on delivering innovative, patient-centered solutions that align with modern healthcare needs.

The organization promotes a culture of authenticity, professional development, diversity, and continuous improvement.

Key Responsibilities

  • Review and approve labeling artwork, including cartons, blisters, inserts, and product labels, ensuring alignment with approved labeling content and regulatory compliance.

  • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure accurate and timely artwork development.

  • Ensure artwork reflects approved prescribing information, including dosage, administration guidelines, safety warnings, and product identifiers.

  • Provide oversight and training to FSP resources involved in artwork and labeling management.

  • Maintain compliance with regional and global regulatory guidelines, including FDA, EMA, ICH, and LATAM authorities.

  • Document artwork reviews, approvals, version history, and change control activities according to internal SOPs.

  • Participate in cross-functional meetings supporting labeling updates, product launches, and lifecycle change management.

  • Contribute to continuous improvement activities related to labeling systems, artwork workflows, and review processes.

Required Skills and Competencies

  • Strong knowledge of regulatory labeling standards (FDA, EMA, ICH).

  • Excellent proofreading, quality-control, and attention-to-detail capabilities.

  • Experience working with artwork management tools such as GLAMS, Adobe Illustrator, or Esko.

  • Familiarity with proofreading tools including TVT and Global Vision.

  • Ability to work both independently and collaboratively in a fast-paced environment.

  • Strong written and verbal communication with advanced organizational skills.

Experience Required

  • Minimum Experience: 4–7 years in regulatory labeling, regulatory affairs, pharmaceutical artwork management, or related functional areas.

  • Industry Background: Life sciences, pharmaceuticals, CROs, or biotechnology.

  • Preferred Experience: Lifecycle product labeling, global regulatory submissions, FSP delivery models, and artwork change control processes.

Compensation and Benefits

Syneos Health provides competitive compensation aligned with experience, skills, and role-specific competencies. Benefits may include medical, dental, and vision insurance, company car or car allowance, 401(k) with company match, employee stock purchase eligibility, annual bonus plans, and flexible paid time off. Benefit availability may vary by region and state regulations.

Role Summary

The Regulatory Labeling Manager – Lifecycle Products oversees the development, maintenance, and documentation of labeling content for mature pharmaceutical products. Responsibilities include updating labeling in response to regulatory changes, safety updates, and internal assessments. The role ensures governance processes are followed and labeling decisions are well documented in accordance with established procedures.