Lifecycle Regulatory Labeling Lead

Syneos Health; Colombia; Presencial; COP 90.000.000 - 150.000.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Regulatory Labeling Manager to oversee labeling content for mature products, ensuring governance and regulatory requirements are met across and ROW markets. This role collaborates with Safety, Medical, Legal, and Regulatory Strategy teams to implement labeling changes and respond to health authority inquiries.

The ideal candidate has 2+ years in biotechnology regulatory labeling or related field, a Bachelor’s degree in a science or business discipline, and strong

Formación

• Experience authoring and maintaining labeling content for approved products.
• Experience supporting labeling negotiations with health authorities.
• Knowledge of safety data interpretation and its impact on labeling.
• Familiarity with XML-based labeling systems and structured content tools.

Responsabilidades

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise labeling documents (CCDSs, USPI, SmPC, ROW) for lifecycle products.
• Support labeling governance meetings; prepare and record minutes and upload in EDDMS.
• Ensure compliance with FDA, EMA, ICH and internal standards.
• Collaborate with cross-functional teams to gather input on labeling changes.
• Respond to health authority queries related to labeling content.
• Coordinate with document specialists and publishing teams for submissions.
• Attend labeling governance meetings and maintain accurate minutes.

Conocimientos

Regulatory labeling

English proficiency

Documentation management

Stakeholder collaboration

Labeling regulations (FDA/EMA/ICH)

Labeling systems

Educación

Bachelor's degree in Science or Business

Herramientas

Veeva Vault

Label tracking systems (Intagras)

Veeva Labeling

Descripción del empleo

Syneos Health is seeking a Regulatory Labeling Manager to oversee labeling content for mature products, ensuring governance and regulatory requirements are met across and ROW markets. This role collaborates with Safety, Medical, Legal, and Regulatory Strategy teams to implement labeling changes and respond to health authority inquiries.

The ideal candidate has 2+ years in biotechnology regulatory labeling or related field, a Bachelor’s degree in a science or business discipline, and strong