Senior Manager, Regulatory Affairs CMC

CSL Seqirus is a global leader in influenza prevention and the world’s second-largest influenza vaccine provider, operating as a specialized division of CSL Limited. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness. Joining Seqirus now means being part of an agile team committed to developing vaccines that make a meaningful difference worldwide.Could you be our next Senior Manager, Regulatory Affairs CMC? The job is in our Holly Springs, NC, Broadmeadows Australia or Liverpool UK Office. This is a hybrid position and is onsite three days a week. You will report to the Team Lead, Global Regulatory Affairs CMC.You will be responsible for:Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.Responsibilities:Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including ne