Senior Regulatory Project Manager
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About The Position
An exciting new opportunity has arisen to join the company as Regulatory Project Manager in Healthcare. As a key partner to the Global Regulatory lead, you will support that the regulatory strategy will be executed as planned. You will create project plans for submissions to Health Authorities worldwide with a focus on initial clinical trial and/or marketing authorization applications and major variations. You will set-up kick-off meetings and regular Submission Task Force meetings for submission preparation with relevant stakeholders. In close interaction with the Regulatory Lead, cross-functional teams, and submission management, you will assess and resolve any issue impacting timeline, and perform spot checks on published outputs. In addition, you will be responsible for providing transparency on Global Regulatory budget demands and tracking of actual spending (if applicable). You are expected to contribute to the improvement of planning capabilities within Regulatory and to increase efficiency in GRA-internal processes. You will manage and improve tools and templates for project management that ensure compliance with regulatory strategy, regulatory project timelines and Health Authority requirements. You will represent Regulatory Project Management in Regulatory Sub teams and Global Project teams.
