Remote Lifecycle Labeling Manager

Syneos Health, Inc.; Washington (District of Columbia); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Syneos Health, Inc. is seeking a Regulatory Labeling Manager – Lifecycle Products to develop, maintain, and oversee labeling for mature products. You will author labeling content and ensure governance and documentation meet FDA, EMA, and ICH standards.

You will collaborate with cross-functional teams, support health authority responses, and deliver timely, submission-ready labeling packages across CCDS, USPI, SmPC, and ROW labels.

Qualifications

• Experience authoring and maintaining labeling content for approved products.
• Strong understanding of FDA, EMA and ICH labeling guidance.
• Bachelor’s degree in a science or business-related field.
• Excellent English grammar, spelling, and punctuation.

Responsibilities

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise labeling documents including CCDS, USPI, SmPC, and ROW labels for lifecycle products.
• Support labeling governance: attend meetings and record accurate minutes.
• Ensure labeling content complies with regulatory requirements and internal standards.
• Collaborate with Safety, Medical, Legal, Regulatory Strategy teams on labeling changes.

Skills

Global labeling regulations

Labeling content authoring

Cross-functional collaboration

English language proficiency

Documentation proofreading

Education

Bachelor’s degree in Science or Business

Tools

Veeva Vault

Intalras

Veeva Labeling

Microsoft Word

Job description

Syneos Health, Inc. is seeking a Regulatory Labeling Manager – Lifecycle Products to develop, maintain, and oversee labeling for mature products. You will author labeling content and ensure governance and documentation meet FDA, EMA, and ICH standards.

You will collaborate with cross-functional teams, support health authority responses, and deliver timely, submission-ready labeling packages across CCDS, USPI, SmPC, and ROW labels.