Associate Director, Global Regulatory Affairs – Global Labeling Strategy - Sanofi : Job Details

Lead the preparation, review, and maintenance of global labeling strategy and content (CCDS, USPI, Sm. PC) for assigned products throughout their lifecycle. Collaborate with clinical, medical, safety, and regulatory colleagues to provide labeling input relevant to clinical study protocols, especially in early and late development phases. Contribute to discussions around clinical endpoint selection and integration of patient experience data to maximize labeling value. Assist in labeling submissions, regulatory queries, and updates to ensure compliance with regulatory expectations and company standards. Support alignment between core global labeling and regional/local labeling requirements. Participate in cross-functional regulatory teams and labeling governance processes. Stay informed of relevant regulatory guidelines, industry trends, and competitor labeling activities. Provide mentoring and training to more junior labeling strategists and support process improvements within the label...Regulatory Affairs, Director, Global, Strategy, Regulatory, Associate, Management