Regulatory Affairs CMC Director (Marketed Product Optimization)

736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, there is more we can do to help improve and extend people’s lives.<br>In Global Regulatory Affairs CMC, our work starts when a compound goes into clinical trials. Novartis has a unique and promising portfolio. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help. <br><br>As a senior 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 complex projects and products covering development, registration and approval/post approval activities.<br><br>Your Responsibilities include but are not limited to:<br><br>• Formulate, lead and drive global CMC regulatory strategy across all therapeutic areas and technology platforms, support projects/products drawing on extensive regulatory expertise with a focus on innovation, improving the business benefit equitable with regulatory risks and compliance<br><br>• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions<br><br>• 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<br><br>• 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<br><br>• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders<br><br>• Initiate and lead Health Authority interactions and negotiations including more complex interactions; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA<br><br>• Act as a role model, providing strategic advice within and outside of RA CMC, driving continuous improvement and building the talent within the team through coaching and mentoring<br>[#video#https://youtu.be/Q0rHKXOfOXo{#400,300#}#/video#]