Global Labeling Strategist

Global Labeling Strategist leads or co-leads the preparation, review, and maintenance of global labeling strategy and content (CCDS, USPI, SmPC) for assigned products throughout their lifecycle, collaborating with clinical, medical affairs, safety, and regulatory colleagues to ensure labeling compliance and alignment with regulatory expectations. The role involves providing labeling input to clinical study protocols (early to late development), guiding endpoints relevant for labeling, integrating patient experience data, assisting in labeling submissions and regulatory inquiries, and mentoring junior labeling strategists while driving process improvements. Core responsibilities include developing and updating labeling documents, ensuring consistency between global and regional/local labeling, and staying informed of regulatory guidelines and industry trends. Required and preferred qualifications include a Bachelor’s degree in life sciences or related field, a strong background in regulatory labeling with 8+ years of industry experience (4+ years in regulatory affairs or labeling), and an advanced degree preferred; experience with CCDS, USPI, and SmPC, plus strong cross-functional collaboration and stakeholder management skills.