Labeling strategist - Reg Affairs AD

Overview

Lead global regulatory labeling strategy and author core labeling documents for new and registered assets. Provide regulatory expertise, client guidance, and cross-functional leadership from development through registration and lifecycle management.

What you'll do

• Define and monitor labeling authoring plans with regulatory and project leads.
• Lead global labeling strategy across US, EU, and Japan regulatory teams.
• Author target product labels, core data sheets, core IFUs, and US labeling.
• Lead and document labeling working groups and global labeling committees.
• Review source documents and labeling impact assessments.
• Advise clients and teams on regulatory strategy, intelligence, and submissions.
• Oversee project quality, budgets, training, and matrix leadership.

What you'll need

• Bachelor's degree or equivalent relevant qualification.
• At least 5 years of global labeling strategy experience.
• Comparable experience of 12+ years, with applicable equivalencies considered.
• Experience with biologics, medical devices, or combination products.
• Experience in clinical development or global regulatory affairs.
• Deep knowledge of global labeling processes, regulatory requirements, and ICH guidelines.
• English communication, analytical, organizational, negotiation, and presentation skills.

Details

• Remote role in Belgium.
• Standard Monday–Friday schedule.
• Occasional domestic and international travel.