576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients' lives and we need your help. As a member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and operational direction and documentation for projects and products covering development, registration and approval/post approval activities.
Your Responsibilities include but are not limited to: * Formulate, lead and drive global CMC regulatory strategy for Biologics projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
* Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions
* Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
* Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
* Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
* Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA
* Provide strategic advice and direction within the department and cross-functionally through specialized assignments