Global Labelling Lead

UCB S.A.; Anderlecht; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

UCB S.A. in Brussels is seeking a Global Labelling Lead to shape and maintain global product labeling strategies across the lifecycle.

You will lead TCLP, CCDS, and other core documents to ensure patient-centered, compliant labeling for submissions, approvals, launches, and lifecycle changes worldwide. The role requires a deep knowledge of global and local labeling regulations, strong cross-functional collaboration, and the ability to balance global consistency with regional regulatory needs.

Qualifications

• A relevant university degree or equivalent in scientific, medical, legal, or regulatory education.
• 8+ years of pharmaceutical experience, including 6+ years in Regulatory Affairs and product launches.
• Deep knowledge of global and local labeling regulations and regulatory strategy.
• Experience developing global labeling strategies, TCLPs, CCDSs, and lifecycle updates.
• Ability to interpret stakeholder and patient needs, set priorities, and meet changing timelines.
• Inclusive communication, sound judgment, integrity, adaptability, and comfort with digital systems.

Responsabilités

• Shape and maintain global product labeling strategies throughout the product lifecycle.
• Lead TCLP, CCDS, and other core documents to support submissions, approvals, launches, and lifecycle changes.
• Collaborate across Global Regulatory Affairs and partner with Clinical Development, Safety, Medical Affairs, Commercial, Market Access, Legal, Quality, and regional teams.
• Provide regulatory labeling expertise for global promotional materials and Above Country Clearance activities.
• Manage labeling governance, updates, and digital transformation initiatives.

Connaissances

Regulatory labeling

TCLP

CCDS

Global regulatory affairs

Cross-functional collaboration

Digital solutions

Formation

University degree in scientific/medical/regulatory field

Description du poste

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 you’ll 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 you’ll 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 you’ll 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 don’t just complete tasks, we create value. We aren’t 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 that’s 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, we’ve 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 [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.