Senior Manager, Regulatory Affairs CMC

Job description

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 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 sup...