Job Description

Why Patients Need You We\'re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines. What You Will Achieve As a Global Labeling Lead, you will manage and direct the development and maintenance of labeling for product registration and commercialization. In your role, you will serve as a regulatory liaison between markets, manufacturing plants and/or project teams throughout the product lifecycle and provide advice on manufacturing changes, line extensions, technical labeling,and appropriate interpretation of regulations. You will be accountable to provide strategic direction to local and global stakeholders on labeling and artwork content, regulatory requirements, and logistics. As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the department. Support the use and development of current and new tools, technologies, and processes to support global label development, submission, and approval. Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements. Liaise and present information to all stakeholders using the most effective means of communication. Review and develop appropriate content for local labeling documents based on existing approved content, seeking strategic and medical input from others as required. Review request for labeling updates and appropriate implementation of defined content, recording the key decisions made. Serve as an SME for the use of relevant tools and technologies within the course of the label development and translation process. Work within a framework of internal SOPs, working practices and external regulatory requirements, so that the high-quality delivery of outputs and compliance is maintained. Support the use of relevant tools and technologies within the course of the label development and translation process. Contribute to the development of continuous improvement of business practices associated with processes and tools. Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams). Qualifications Must-Have Bachelor\'s Degree (BA/BS) and 5+ years of experience. Demonstrated project management, attention to detail and problem solving skills. Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures. Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts. Excellent written and verbal communication skills essential. Nice-to-Have Master\'s degree (MA/MBA/MS) and 3+ years of experience. Doctorate Degree (PhD/PharmD/JD). Demonstrated project management experience. Attention to detail and problem solving skills. Ability to negotiate, influence and problem solve. Work Location Assignment:Flexible Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs#LI-PFE

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