Regulatory Labeling Manager (Na And Latam Only)

Syneos Health

5-7 years

Not Disclosed

Remote

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 & LATAM Only) – Remote

Updated: December 6, 2025
Location: USA–MN–Remote
Job ID: 25103967

Position Overview

Syneos Health is seeking a highly skilled Regulatory Labeling Manager to support global labeling functions for mature pharmaceutical products. This remote position is open exclusively to candidates located in North America or LATAM and does not provide sponsorship.

The role focuses on reviewing labeling artwork, managing lifecycle labeling updates, and ensuring global compliance with regulatory standards. The ideal candidate will have strong technical expertise in regulatory labeling, exceptional attention to detail, and experience collaborating with cross-functional teams.

Key Responsibilities

Review and approve labeling artwork such as cartons, blister packs, inserts, and product labels for regulatory accuracy, readability, and compliance.
Ensure alignment of artwork with approved prescribing information, including dosage, administration guidance, safety warnings, and product identification.
Work closely with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to support timely artwork creation and updates.
Provide training, oversight, and guidance to additional FSP resources engaged in artwork management activities.
Maintain thorough documentation of artwork reviews, approvals, and version control according to internal SOPs.
Participate in cross-functional meetings related to product launches, labeling updates, change control processes, and governance reviews.
Ensure compliance with regulatory requirements from health authorities including FDA, EMA, and other global agencies.
Contribute to continuous improvement initiatives focused on artwork review processes and labeling systems.

Required Knowledge and Skills

Strong understanding of global regulatory labeling requirements (FDA, EMA, ICH).
Exceptional proofreading capability and attention to detail for quality control.
Familiarity with artwork and labeling systems such as GLAMS, Adobe Illustrator, and Esko.
Experience using proofreading tools such as TVT or Global Vision.
Strong communication, documentation, and organizational skills.
Ability to work both independently and collaboratively in a fast-paced environment.

Experience Required

Minimum 5–7 years of experience in regulatory labeling, regulatory affairs, labeling operations, artwork management, or lifecycle labeling roles within the pharmaceutical or biotechnology industry.
Experience reviewing, developing, or approving labeling artwork for commercial products.
Hands-on experience with labeling systems, version control processes, and documentation management.
Prior involvement in cross-functional labeling or regulatory activities is preferred.

Compensation and Benefits

Syneos Health offers a competitive total rewards program which may include:

Medical, Dental, and Vision benefits
Company car or car allowance (role-dependent)
Company-matched 401(k)
Eligibility for Employee Stock Purchase Plan
Performance-based bonus opportunities
Flexible paid time off and sick leave compliant with applicable state and local laws

Salary Range:
The base salary range reflects the anticipated compensation for this role. Final salary is determined based on skills, experience, and job-related competencies.

About Syneos Health

Syneos Health is a global leader in fully integrated biopharmaceutical solutions, supporting clinical development and commercialization across more than 110 countries. The company has worked with:

94 percent of all novel FDA-approved drugs
95 percent of EMA-authorized products
Over 200 clinical studies across 73,000 sites and 675,000+ patients

The organization is committed to professional growth, diversity, inclusion, and creating a workplace where every employee can thrive.

Role Summary

The Regulatory Labeling Manager – Lifecycle Products is responsible for developing, updating, and overseeing labeling content for established pharmaceutical products. This includes managing updates driven by safety requirements, regulatory changes, or internal assessments. The role ensures compliance with labeling governance processes and maintains clear documentation in alignment with organizational labeling procedures.

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Regulatory Labeling Manager (Na And Latam Only)

Job Description

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