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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 – VA)
Job ID: 25103967
Updated: December 6, 2025
Status: This job posting is no longer active

Position Overview

The Regulatory Labeling Manager is responsible for reviewing, developing, and maintaining labeling content and artwork for pharmaceutical products across North America and LATAM. This role ensures adherence to global regulatory standards, supports lifecycle labeling activities, and collaborates with cross-functional teams to meet quality and compliance expectations.

This position is open exclusively to candidates based in North America and LATAM and does not offer sponsorship.

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical, medical, and commercial success. With more than 29,000 employees across 110 countries, the organization delivers insights-driven, patient-centered services designed to streamline development and improve outcomes.

The company is committed to a culture that values authenticity, professional growth, diversity of thought, and collaborative innovation.

Key Responsibilities

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

  • Ensure artwork reflects approved prescribing information, including dosage, administration instructions, safety warnings, and product identification elements.

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

  • Ensure compliance with regional and global regulatory authorities, including FDA, EMA, ICH, and LATAM agencies.

  • Maintain accurate documentation of artwork reviews, approvals, and version history in line with SOPs.

  • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.

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

Required Skills and Competencies

  • Strong understanding of global regulatory labeling requirements (FDA, EMA, ICH).

  • Exceptional proofreading, accuracy, and quality-control skills.

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

  • Familiarity with proofreading tools such as TVT and Global Vision.

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

  • Strong written and verbal communication skills with excellent organization and documentation abilities.

Experience Required

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

  • Industry Experience: Biopharmaceutical, clinical research, or life sciences environment.

  • Preferred: Experience supporting lifecycle products, labeling change control, or working within a Functional Service Provider model.

Compensation and Benefits

Syneos Health offers a competitive salary based on skills, experience, and role proficiency. Benefits may include medical, dental, and vision coverage, company car or car allowance, 401(k) with company match, eligibility for the Employee Stock Purchase Plan, bonus programs, and flexible paid time off. Benefit availability varies by region and local regulations.

Summary

The Regulatory Labeling Manager – Lifecycle Products oversees labeling content development for mature pharmaceutical products, ensuring compliance with safety updates, regulatory guidance, and internal governance. This role requires effective cross-functional collaboration and strong documentation practices aligned with established labeling procedures.