Global Labelling Lead
HybridBrussels, Brussels Capital, Belgium
Job Summary
Develop and maintain the Target Core Labeling Profile (TCLP) and Company Core Data Sheet (CCDS) to translate scientific evidence and health authority expectations into compliant, patient-focused labeling. Lead cross-functional TCLP development by aligning clinical, safety, regulatory, market access, and commercial perspectives while guiding regional teams on timely CCDS implementation. Provide regulatory expertise for global promotional materials, external communications, and Above Country Clearance activities. Manage labeling governance, risks, updates, and digital transformation initiatives to improve quality and efficiency. This role requires a university degree in a relevant scientific, medical, legal, or regulatory field, at least eight years of pharmaceutical experience including six in Regulatory Affairs, and deep knowledge of global labeling regulations. The position is based in Brussels with a hybrid-first approach, requiring 40% office time. UCB is a global biopharmaceutical company focused on neurology and immunology, inspiring patients and driven by science.
Required Qualifications
- 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
- Six years in Regulatory Affairs
- Experience supporting a product launch
- Deep knowledge of global and local labeling regulations
- Deep knowledge of regulatory strategy
- Deep knowledge of scientific data
- Deep knowledge of competitive context
- Experience developing and implementing global labeling strategies
- Experience developing and implementing TCLPs
- Experience developing and implementing CCDSs
- Experience developing and implementing lifecycle updates
- Ability to interpret stakeholder and patient needs
- Ability to set priorities
- Ability to manage uncertainty
- Ability to deliver accurate work within changing timelines
- Inclusive communication
- Sound judgment
- Integrity
- Adaptability
- Confidence using electronic documentation systems
- Exploring innovative digital solutions
- 40% of your time spent in the office
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