At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members. Responsibilities: Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements Support labeling negotiations with FDA and manage implementation of approved labeling updates Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner Ensure compliance with FDA regulations, including: FD&C Act requirements FDA advertising and promotion regulations OPDP guidance and
