Regulatory Labelling Specialist
4 weeks ago
Senior / Labelling Specialist
Job 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
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