Lifecycle Regulatory Labeling Manager

Syneos Health; Madrid; Presencial; EUR 60.000 - 95.000; Jornada completa

Descripción de la vacante

Syneos Health in Madrid seeks a Regulatory Labeling Manager for Lifecycle Products to develop, maintain, and oversee labeling content for mature pharmaceutical products. You will ensure governance, update labeling in response to safety updates and regulatory requirements, and collaborate with internal stakeholders.

The role requires experience with health authorities negotiations, safety data interpretation, and XML-based labeling systems, plus preparation of labeling components for eCTD

Formación

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

Responsabilidades

• Develop, maintain, and oversee labelling content for mature pharmaceutical products.
• Collaborate with internal stakeholders to ensure governance processes are followed and labeling decisions are well‑documented.

Conocimientos

Labelling negotiations

Safety data interpretation

Educación

Bachelor's degree in Science or Business

Herramientas

XML-based labelling systems

eCTD submissions preparation

Descripción del empleo

Syneos Health in Madrid seeks a Regulatory Labeling Manager for Lifecycle Products to develop, maintain, and oversee labeling content for mature pharmaceutical products. You will ensure governance, update labeling in response to safety updates and regulatory requirements, and collaborate with internal stakeholders.

The role requires experience with health authorities negotiations, safety data interpretation, and XML-based labeling systems, plus preparation of labeling components for eCTD