Experteer Overview
In this role you lead the development, maintenance, and oversight of labeling content for mature pharmaceutical products. You collaborate with internal stakeholders to ensure labeling governance is followed and decisions are well-documented. You’ll translate safety updates and regulatory changes into compliant labeling components and support eCTD submissions. This position offers the chance to shape labeling strategy within a fast‑moving lifecycle environment and contribute to patient safety and product success. You will work with cross‑functional teams in a mission‑driven culture committed to delivering meaningful healthcare impact.

Compensaciones / Ventajas
• Develop and maintain labeling content for mature products
• Author and update labeling documents in response to safety updates and regulatory requirements
• Ensure governance processes are followed and labeling decisions are well-documented
• Collaborate with internal stakeholders for labeling governance and lifecycle management




• Prepare labeling components for eCTD submissions
• Support health authority negotiations related to labeling (where applicable)
• Interpret safety data and assess impact on labeling
• Utilize structured content authoring tools or XML-based labeling systems

Responsabilidades
• 2+ years in Regulatory Affairs, Regulatory Labeling or related discipline in biotech/biopharma
• Bachelor's degree in Science or related field
• Experience supporting labeling negotiations with health authorities
• Knowledge of safety data interpretation and its impact on labeling
• Familiarity with XML-based labeling systems or structured content authoring tools
• Experience preparing labeling components for eCTD submissions

Requisitos principales
• career development and progression
• supportive line management
• technical and therapeutic area training
• peer recognition
• total rewards program

📌 Sponsor Dedicated - Regulatory Labeling Manager (Madrid)
🏢 Syneos Health
📍 Madrid