Regulatory Labeling Manager – Lifecycle Products Job Responsibilities Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews. Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products. Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting, and record accurate minutes for upload into the electronic document management system. Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards. Collaborate with cross‑functional teams (Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes. Support responses to health authority queries related to labeling content. Partner with document specialists and publishing teams to ensure submission‑ready formatting and timely delivery. Attend labeling governance meetings and draft accurate minutes for electronic filing. Required Knowledge and Skills Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH). Proven experience authoring and maintaining labeling content for approved products. Excellent command of the English language, including grammar, spelling, punctuation, and exceptional proofreading and editing skills. Strong organizational skills and attention to detail. Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault). Experience using label tracking systems, e.g., Intagras, Veeva Labeling. Ability to communicate and work effectively with labeling stakeholders. Required Experience & Education Experience supporting labeling negotiations with health authorities. Knowledge of safety data interpretation and its impact on labeling. Familiarity with structured content authoring tools or XML‑based labeling systems. Experience preparing labeling components for eCTD submissions. Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling, or a related discipline. Minimum Bachelor’s degree in a Science or Business‑related field. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, and to Equal Opportunity employment in all forms. #J-18808-Ljbffr