Lifecycle Labeling Manager - Regulatory Affairs

Syneos Health; Colombia; Presencial; COP 30.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

Syneos Health seeks a Regulatory Labeling Manager to oversee labeling content for mature pharmaceutical products. You will author and update CCDS, USPI, SmPC and ROW labels, ensuring compliance with FDA/EMA/ICH standards and internal processes.

You will coordinate with cross-functional teams to implement safety-driven labeling changes, manage governance activities, and prepare submission-ready materials for health authorities.

Formación

• Bachelor's degree in Science or Business-related field.
• 2+ years in biotechnology, regulatory labeling or related discipline.
• Experience authoring and maintaining labeling for approved products.
• Knowledge of FDA/EMA/ICH labeling guidance and safety data interpretation.
• Proficiency in Word and document management systems (e.g., Veeva Vault).

Responsabilidades

• Plan and lead labeling updates driven by safety changes and regulatory commitments.
• Author and revise labeling documents (CCDS, USPI, SmPC, ROW labels) for lifecycle products.
• Support labeling governance activities; attend meetings and record minutes.
• Ensure labeling content complies with regulatory requirements and internal standards.
• Collaborate with Safety, Medical, Legal, Regulatory Strategy to align on changes.
• Support responses to health authority queries and prepare submission-ready formatting.

Conocimientos

Global labeling regulations

Authoring labeling content

English grammar & proofreading

Organizational skills

MS Word / document mgmt systems

Label tracking systems

Stakeholder collaboration

Educación

Bachelor's degree in Science or Business

Herramientas

Veeva Vault

Label tracking tools

XML-based labeling systems

Descripción del empleo

Syneos Health seeks a Regulatory Labeling Manager to oversee labeling content for mature pharmaceutical products. You will author and update CCDS, USPI, SmPC and ROW labels, ensuring compliance with FDA/EMA/ICH standards and internal processes.

You will coordinate with cross-functional teams to implement safety-driven labeling changes, manage governance activities, and prepare submission-ready materials for health authorities.