职位描述

职位描述： Delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, Legalizations, Promotional Materials and post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. U.S. promotional activities, drug listing and establishment registrations, legalizations, and scheduled regulatory compliance reporting.Subject matter expert of Pfizer’s positions in support of proposed changes to CFR, Federal Register notices for rule changes as well as local process experts across organizational lines.??Key Accountabilities:??Delivery of Product License Support Portfolio?Solution implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes.?Knowledge share and educate personnel as appropriate on agency requirements and guidelines.?Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.?Process development and change management in the context of PLS submissions?liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these?utilization support of electronic technologies for submissions and tracking of documentation?Matrix management of cross-functional teams as appropriate?Development and maintenance of documented procedures and guidelines as necessaryTechnical Skill Requirements?Demonstrated knowledge of CFR as it relates to specific post-market submissions for Drug Listing and DDMAC divisions at FDA?Demonstrated knowledge of/experience with Pfizer Commercial Portfolio?Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format?Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines?Demonstrated ability to work with or lead a team in a matrix structure?Global perspective within the context of business needs and impactQualifications (i.e., preferred education, experience, attributes)?Undergraduate degree plus relevant experience as below, or?Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.?Demonstrated ability to function autonomously in a matrixed environment.?Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems?Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.?Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools. 职能类别： 医药技术研发管理人员

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