Regulatory Labeling Manager – NA, LATAM

Syneos Health

Regulatory Labeling Manager responsible for leading labeling updates and ensuring compliance with regulations in North America and LATAM. Collaborating with teams for document management and approvals.

Posted 5/8/2026full-timeRemote • Arizona, Maine, Massachusetts, Ohio, Rhode Island • 🇺🇸 United StatesMid-LevelSeniorWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews
Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products
Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting and record accurate minutes in a timely manner to upload in the electronic document management system, and ensure required approvals are obtained
Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards
Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes, as needed
Support responses to health authority queries related to labeling content
Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery
Attend labeling governance meetings and draft accurate minutes in a timely manner
Upload minutes to the electronic document management system

Requirements

What you’ll need

Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH)
Proven experience authoring and maintaining labeling content for approved products
A strong command of English language including grammar, spelling, and punctuation and exceptional proofreading and editing skills
Strong organizational skills and attention to detail
Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault)
Experience using Label tracking systems, e.g. Intagras, Veeva Labeling
Ability to communicate and work effectively with labeling stakeholders

Benefits

Comp & perks

Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

labeling content authoringlabeling document revisionproofreadingeditingregulatory compliancelabel tracking systemsdocument management systems

Soft Skills

organizational skillsattention to detailcommunicationcollaboration