Labeling Strategist – Regulatory Affairs AD

• Define and monitor authoring plans with the Global Regulatory Lead and Project Managers
• Lead global labeling strategy with cross-functional US, EU, and Japan regulatory teams
• Author target product labels, Company Core Data Sheets, core IFUs, US labels, prescribing information, patient information, and related documents
• Lead and document labeling working groups and global labeling committees
• Attend and contribute to Global Regulatory Team and submission teams
• Review and contribute to label source documents, regulatory submissions, clinical documents, safety reports, and related materials
• Develop global labeling implementation plans with Labeling Operations Managers
• Supervise US mock-ups and Structured Product Labeling activities
• Evaluate global and US labeling impact assessments and support database documentation
• Assist with local dossier preparation and responses to Health Authority questions
• Support publication of the labeling section of US eCTD dossiers
• Serve as Global Labeling Committee Chairperson and provide oversight of committee requests
• Act as global labeling expert in Safety Management Teams
• Supervise labeling contributions to PSUR/PBRER, PSMF, US annual reports, and other regulatory procedures
• Create, contribute to, and maintain labeling-related procedures
• Participate in pharmacovigilance inspector or auditor interviews
• Provide technical advice and review for regional and global regulatory submissions
• Advise internal and external clients on regulatory strategy, legislation, and guidance
• Ensure quality performance and compliance for managed projects
• Manage project budgeting and forecasting and identify out-of-scope contract activities
• Collaborate with business development on client presentations, proposals, pricing, and budgets
• Oversee matrix/project leadership, training, and guidance for junior team members
• Lead launch, review, project-team, and departmental initiative meetings

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• At least 5 years of experience in global labeling strategy
• Previous experience in biologic products, medical devices, or combined products
• Previous experience in clinical development and/or a global regulatory affairs environment
• 12+ years of comparable knowledge, skills, and abilities to perform the job
• Equivalent combination of appropriate education, training, and/or directly related experience may be considered
• Deep knowledge of clinical development and end-to-end labeling processes
• Knowledge of eCTD dossiers, labeling content, and labeling compliance management
• Knowledge of regulatory, labeling, and clinical intelligence databases
• Knowledge of Regulatory Information Management Systems and Electronic Document Management Systems such as Veeva Vault
• Proficiency with Adobe Acrobat Pro, Microsoft Word, Excel, and PowerPoint
• Mastery of English written and oral communication skills, as well as the local language where applicable
• Exceptional attention to detail and editorial/proofreading skills
• Advanced understanding of global, regional, and national regulatory requirements and procedures
• Expert knowledge of ICH and other global regulatory guidelines
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Excellent budgeting and forecasting understanding
• Professional negotiation, presentation, organizational, time-management, analytical, investigative, and problem-solving skills
• Ability to work independently, exercise judgment, and manage multiple projects

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Occasional domestic and international travel