Regulatory Affairs Specialist

Site Name: Korea - Seoul Posted Date: Jan 11 2023 Regulatory Affairs Specialist The Regulatory Specialist will play a key role in submissions to ensure the successful delivery of an overall regulatory plan. The specialist will lead interactions with the LOC’s and central teams, ensuring regulatory plans are able to meet the business goals. The role will be exposed to a variety of regulatory activities and, in time, will be given the opportunity to take on more strategic regulatory responsibilities as the role grows alongside personal capability and potential. Key Responsibilities Responsibility for the leadership of, preparation, and review of day to day regulatory submissions with full accountability for delivery Accountability for larger submissions as part of an overall project plan i.e. initial submissions and responses to questions Working with the Global Regulatory Lead/Regional representative/Team Manager, to develop a regulatory strategy Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within the required timelines Liaising with Regulatory Agencies to resolve straightforward issues in relation to their accountabilities Implementation of the submission strategy Responsible for the maintenance activities associated with an Approved product / Investigational products Requirements 5+ years of relevant experience in regulatory affairs including the leadership and delivery of a range of regulatory submissions Bachelor’s Degree in pharmacy or biological or chemical science Knowledge of regulatory agency guidelines and expectations in the submission process Experience in the regulatory agency review process *LI-GSK [지원시 필독사항] 이력서를 PDF 파일 한 개로 지원 부탁 드립니다. 온라인 지원시