Global Labelling Lead

Make your mark for patients

We are looking for a Global Labelling Lead who is strategic collaborative and detail-focused to join our Global Regulatory Affairs team based in our HQ in Brussels.

About the role

You will shape and maintain global product labeling strategies throughout the product lifecycle. As the regulatory labeling expert for assigned products you are going to lead the Target Core Labeling Profile (TCLP) Company Core Data Sheet (CCDS) and other core documents. You will turn scientific evidence health authority expectations and product strategy into accurate patient-focused compliant labeling that supports submissions approvals launches and lifecycle changes worldwide.

Who youll work with

You will work across Global Regulatory Affairs and partner with Clinical Development Safety Medical Affairs Commercial Market Access Legal Quality and regional regulatory teams. You are going to bring these perspectives together guide clear decisions and help teams balance global consistency with regional requirements. You will also contribute to labeling governance promotional review forums process improvement and digital initiatives including responsible use of AI-enabled solutions.

• What youll do
• You will develop and maintain the TCLP using emerging evidence and market insights to support differentiated patient-focused product strategies.
• You will lead cross-functional TCLP development and align clinical safety regulatory market access and commercial perspectives.
• You will be responsible for creating reviewing and maintaining the CCDS in line with global requirements and the company core position.
• You will guide regional teams on timely CCDS implementation supporting consistent local labeling while considering market-specific regulatory requirements.
• You will provide regulatory labeling expertise for global promotional materials external communications co-creation and Above Country Clearance activities.
• You will manage labeling governance risks updates process improvements digital transformation and adoption of technologies that improve quality and efficiency.

Interested For this position youll need the following education experience and skills:

• A relevant university degree or equivalent scientific medical legal or regulatory education that supports success in global pharmaceutical labeling.
• At least eight years of relevant pharmaceutical experience preferably including six years in Regulatory Affairs and experience supporting a product launch.
• Deep knowledge of global and local labeling regulations regulatory strategy scientific data competitive context and how evidence becomes clear labeling language.
• Experience developing and implementing global labeling strategies TCLPs CCDSs and lifecycle updates across functions and regions.
• Ability to interpret stakeholder and patient needs set priorities manage uncertainty and deliver accurate work within changing timelines.
• Inclusive communication sound judgment integrity adaptability and confidence using electronic documentation systems and exploring innovative digital solutions.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Employment Type : Full Time
Experience: years
Vacancy: 1