Global Regulatory Labeling Leader for Lifecycle Products

Syneos Health; México; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. The role involves authoring, updating, and governance of labeling in response to safety updates and regulatory requirements.

You will collaborate with Safety, Medical, Legal, and Regulatory teams to ensure compliant labeling across CCDS, USPI, SmPC, and ROW labels for lifecycle products.

Formación

• Experience creating and maintaining labeling content for approved products.
• Experience with regulatory labeling in biotech/pharma environments.
• Strong understanding of FDA, EMA, ICH labeling guidance.
• Excellent written and spoken English.
• Experience preparing labeling components for eCTD submissions.

Responsabilidades

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise labeling documents (CCDSs, USPI, SmPC, ROW labels) for lifecycle products.
• Support labeling governance with team lead and governance meetings.
• Ensure labeling content complies with regulatory requirements and internal standards.
• Collaborate with Safety, Medical, Legal, Regulatory to gather input.
• Assist with health authority responses related to labeling content.
• Coordinate with document specialists and publishing teams for submission-ready formatting.
• Attend governance meetings and maintain accurate minutes.

Conocimientos

Labeling regulations

Authoring labeling content

Stakeholder collaboration

English proofreading

Regulatory affairs

Document management systems

Communication with health authorities

Leadership and governance

Educación

Bachelor's degree in Science or Business

Herramientas

Microsoft Word

Veeva Vault

Intagras

Veeva Labeling

Descripción del empleo

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. The role involves authoring, updating, and governance of labeling in response to safety updates and regulatory requirements.

You will collaborate with Safety, Medical, Legal, and Regulatory teams to ensure compliant labeling across CCDS, USPI, SmPC, and ROW labels for lifecycle products.