Lifecycle Labeling Lead - Global Regulatory Content

Syneos Health, Inc; Antioquia; Presencial; COP 264.082.000 - 341.753.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Descripción de la vacante

Syneos Health is seeking a Regulatory Labeling Manager to lead the development, maintenance, and oversight of labeling content for mature pharmaceutical products, ensuring governance and regulatory compliance across FDA, EMA, and ICH requirements.

You will collaborate with Safety, Medical, Legal, Regulatory Strategy, and publishing teams to produce submission-ready labeling documents (USPI, SmPC) and manage governance minutes and eCTD-ready components.

Formación

• Strong knowledge of FDA, EMA and ICH labeling regulations.
• Proven experience authoring and maintaining labeling content for approved products.
• Excellent command of English grammar, spelling and proofreading.
• Strong organizational skills and meticulous attention to detail.
• Proficiency with Word and document management systems (e.g., Veeva Vault).
• Experience with label tracking systems (Intagras, Veeva Labeling).
• Ability to communicate with labeling stakeholders effectively.
• Typically 2+ years in biotech regulatory labeling or related discipline.

Responsabilidades

• Plan and lead labeling updates driven by safety changes, regulatory commitments and periodic reviews.
• Author and revise labeling documents including CCDS, USPI, SmPC and ROW labels for lifecycle products.
• Support labeling governance activities by collaborating with team lead and GLL/RLL; attend governance meetings and record minutes.
• Ensure labeling content complies with FDA, EMA, ICH and internal standards.
• Collaborate with Safety, Medical, Legal and Regulatory Strategy to align labeling changes.
• Support responses to health authority queries related to labeling content.
• Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery.
• Attend labeling governance meetings and upload minutes to the electronic document management system.

Conocimientos

Labeling regulations

Labeling authoring

English proficiency

Organizational skills

MS Word / DMS

Label tracking systems

Stakeholder communication

Educación

Bachelor's degree in Science or related field

Herramientas

Veeva Vault

Descripción del empleo

Syneos Health is seeking a Regulatory Labeling Manager to lead the development, maintenance, and oversight of labeling content for mature pharmaceutical products, ensuring governance and regulatory compliance across FDA, EMA, and ICH requirements.

You will collaborate with Safety, Medical, Legal, Regulatory Strategy, and publishing teams to produce submission-ready labeling documents (USPI, SmPC) and manage governance minutes and eCTD-ready components.