Manager, Core Labeling Strategy

Role: Manager, Core Labeling Strategy, responsible for developing and maintaining global product labeling to ensure compliance with regulatory standards. Responsibilities: lead creation and updates of core labeling (CCDS, patient info), support regional labeling (EU SmPC, USPI), contribute to strategic labeling initiatives (Target Product Labeling, competitive analysis), and review promotional and scientific materials for regulatory alignment. Collaborate with Regulatory, Medical, Safety, and Clinical teams to ensure scientific accuracy and regulatory compliance; participate in or lead Product Labeling Teams and liaise with external forums. Qualifications: Bachelor's in Science, Medicine, Pharmacy, or related, with 3-5 years' experience in global labeling; experience supporting regulatory submissions (NDA/BLA/MAA) preferred. Advanced degrees (MSc, PharmD, PhD) considered advantageous. Skills: strong interpersonal, communication, and influencing abilities; autonomous work style; ability to manage complex scientific and regulatory issues. High-Value: Expertise in global core labeling (CCDS), regional labeling (USPI, EU SmPC), and regulatory strategy support within the biopharma space, ideally with experience supporting NDA/BLA submissions. WorkSetup: not specified.