Regulatory Labeling Manager — Lifecycle Products (Madrid)

Syneos Health, Inc.; Madrid; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. in Madrid seeks a Sponsor Dedicated Regulatory Labeling Manager to lead labeling content for mature products. You will collaborate with cross-functional teams to ensure labeling accuracy and regulatory compliance.

The role involves preparing labeling components for eCTD submissions and coordinating with health authorities where needed. The position requires 2+ years in regulatory labeling or related fields, a Bachelor's degree in Science or Business, and strong interpretation

Formación

• Experience supporting labeling negotiations with health authorities.
• Knowledge of safety data interpretation and its impact on labeling.
• Familiarity with structured content authoring tools or XML-based labeling systems.
• Experience preparing labeling components for eCTD submissions.
• Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling or a related discipline.
• Minimum Bachelor's degree, in a Science or Business-related field

Responsabilidades

• Develop, maintain, and oversee labeling content for mature products.
• Collaborate with internal stakeholders to ensure governance and documentation of labeling decisions.
• Prepare labeling components for eCTD submissions.
• Support labeling negotiations with regulatory authorities.

Conocimientos

Labeling negotiations

Safety data interpretation

Biotech industry knowledge

Cross-functional collaboration

Educación

Bachelor's degree in Science or Business-related field

Herramientas

XML-based labeling systems

Structured content authoring tools

Descripción del empleo

Syneos Health, Inc. in Madrid seeks a Sponsor Dedicated Regulatory Labeling Manager to lead labeling content for mature products. You will collaborate with cross-functional teams to ensure labeling accuracy and regulatory compliance.

The role involves preparing labeling components for eCTD submissions and coordinating with health authorities where needed. The position requires 2+ years in regulatory labeling or related fields, a Bachelor's degree in Science or Business, and strong interpretation