Lifecycle Regulatory Labeling Manager

Syneos Health; Mexico; On-site; PHP 4,988,000 - 6,858,000; Full time

Job summary

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to develop, maintain, and oversee labeling content for mature pharmaceutical products. You will author and update documents like CCDS, USPI, SmPC, and ROW labels, ensuring governance and regulatory compliance across FDA, EMA, and ICH standards.

You will collaborate with cross-functional teams to gather input, support health authority queries, and deliver submission-ready labeling.

Qualifications

• 2+ years of experience in biotechnology or regulatory labeling.
• Bachelor's degree in science or business.
• Knowledge of safety data interpretation and impact on labeling.
• Experience with XML-based labeling or structured content tools.
• Experience preparing labeling components for eCTD submissions.

Responsibilities

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise CCDS, USPI, SmPC, and ROW labels for lifecycle products.
• Support labeling governance with team lead, meetings, and minutes.
• Ensure labeling content complies with FDA/EMA/ICH requirements and internal standards.
• Collaborate with Safety, Medical, Legal, Regulatory Strategy teams.
• Prepare submissions-ready labeling components and participate in governance meetings.

Skills

Labeling regulations

Labeling content

English proficiency

Organizational skills

Word & DMS

Label tracking

Stakeholder comms

Education

Bachelor's degree

Tools

Veeva Vault

Intagras

Veeva Labeling

Job description

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to develop, maintain, and oversee labeling content for mature pharmaceutical products. You will author and update documents like CCDS, USPI, SmPC, and ROW labels, ensuring governance and regulatory compliance across FDA, EMA, and ICH standards.

You will collaborate with cross-functional teams to gather input, support health authority queries, and deliver submission-ready labeling.