Head Global Labelling, Promotion & Advertisement

• Responsible for providing regulatory leadership for the Labelling community by ensuring partnership between Global and Regional Labelling teams and cross- functional stakeholders.
• Recruit, develop, and retain highly talented and skilled Labelling leads and scientists.
• Epitomize and drive a culture of accountability and excellence, motivating employees to perform at their highest ability.
• Active and contributing member of the GRA-LT and Secretary of the GLC.
• Accountable for creation and maintenance of Target Core Labelling Profile (TCLP), CCDS, Prescribing Information (PI), Patient Information Leaflet (PIL or med guide), and Instructions for Use (IFUs).
• Fosters an organizational culture that “labelling aids in driving development.”
• Oversees delivery of differentiated assets via Target Core Label Profile (TCLP) and CCDS.
• Oversees that TCLP and CCDS process leads to well-crafted and competitive regional labels.
• Oversees strategic and compliant lifecycle maintenance of labelling activities.
• Is accountable for the process of Regulatory review of Promotional & Non-Promotional Materials.
• Ensures appropriate alignment in review of promotional materials or scientific communications at global level.
• Accountable for all general Labelling training, responsible for creating and maintaining specific training for Labelling Leads and create consistency by ensuring best practices and learnings are shared across therapeutic areas and/or products.

• Bachelor’s degree required, master’s preferred.
• Significant pharmaceutical industry experience. This is inclusive of several years of labelling experience or a combination of regulatory affairs and labelling and/or related experience.
• Global labelling experience for core countries: (US & EU - required; and JP and CN preferred), with a proven track record of approved labels with business-driven differentiated profile.
• Thorough understanding of global drug development processes that connect with global labelling regulatory requirements and processes.
• Has developed a strategic network in the external labeling community.
• Up to date knowledge of the global labelling environment, expert understanding of the complex set of regulations within which the organization operates and maintains an awareness of the subtleties of regulations worldwide.

UCB