Senior / Labelling SpecialistJob Description:We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial document preparation to coordination with regulatory agencies and senior management. This role requires a deep understanding of regulatory requirements, strong leadership abilities, and excellent communication skills to collaborate effectively with cross-functional teams.Key Responsibilities:Labelling Document Preparation:Draft and finalize corporate, US, and EU labelling documents, including prescribing information and patient information, for developmental, mature, and marketed products within the vaccine portfolio.Ensure compliance with regional regulatory guidelines and requirements while maintaining consistency and accuracy in labelling content.Contribution to Regulatory Strategies:Provide expertise in labelling to contribute to the definition of global regulatory strategies.Interpret regulatory requirements and ensure that labelling strategies align with broader regulatory objectives and corporate goals.Submission Dossiers and Responses:Play a key role in preparing submission dossiers and responses to Health Authorities, focusing on labelling-related aspects to ensure accuracy, compliance, and strategic alignment.Leadership of Labelling Working Group (LWG):Lead a multidisciplinary LWG comprised of representatives from Global Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, Communications, preclinical, and CMC.Facilitate collaboration, knowledge sharing, and alignment across functional areas to drive labelling-related initiatives forward.Coordination with Senior Executive Management:Coordinate the presentation of LWG proposals to Senior Executive Management through a Labelling Review Committee.Prepare presentations, synthesize input from the LWG, and facilitate discussions to obtain senior management approval for labelling strategies and documents.Support for Transversal Projects:Provide labelling expertise and support for transversal projects that have implications for labelling or require labelling input.Collaborate with other functional teams to ensure that labelling considerations are integrated into broader initiatives such as product launches and lifecycle management