Remote Regulatory Labeling Manager – Lifecycle Products

Syneos Health, Inc.; Greater London; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

The Regulatory Labeling Manager for Lifecycle Products at Syneos Health is responsible for development, maintenance, and oversight of labeling content for mature pharmaceutical products. You will author and update labeling documents in response to safety updates and regulatory requirements, coordinating with stakeholders to ensure governance processes are followed.

You will work with internal teams across drug development and commercialization to ensure timely and compliant labeling decisions,

Qualifications

• 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

Responsibilities

• Develop, maintain and oversee labeling content for mature pharmaceutical products.
• Collaborate with internal stakeholders to ensure governance processes are followed.
• Update labeling in response to safety updates and regulatory requirements.

Skills

Labeling negotiations

Safety data interpretation

Structured content tools

eCTD labeling submissions

Biotech Regulatory labeling

Bachelor's degree • Science/Business

Education

Bachelor's degree in Science or Business

Tools

XML-based labeling systems

Structured content authoring tools

Job description

The Regulatory Labeling Manager for Lifecycle Products at Syneos Health is responsible for development, maintenance, and oversight of labeling content for mature pharmaceutical products. You will author and update labeling documents in response to safety updates and regulatory requirements, coordinating with stakeholders to ensure governance processes are followed.

You will work with internal teams across drug development and commercialization to ensure timely and compliant labeling decisions,