Regulatory Submission Manager

Senior Manager, Regulatory Submission Locations: King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UK Work Arrangement: Hybrid — 3 days onsite Reports to: Global Submission Management Lead CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we’re building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world. The Opportunity Could you be our next Senior Manager, Regulatory Submission? As a key member of the Global Regulatory Submission Management Team, you will help ensure the timely, high-quality, and compliant delivery of regulatory submissions across global markets. You will work closely with Regulatory, Project Management, Publishing, cross-functional teams, and external partners to coordinate submission activities, manage risks, and ensure adherence to global regulatory and publishing standards. This is a hands-on leadership role that combines submission management, vendor oversight, regulatory publishing, planning, and process improvement. While much of the publishing activity is managed by external partners, you will provide oversight and may step in directly to publish or coordinate submissions when needed. What You’ll Do Oversee external publishing and Global Submission Coordinator activities, ensuring work is delivered according to quality, compliance, and timeline expectations. Manage vendor performance, resource allocation, operational standards, and business continuity while contributing to the evolution of the global vendor operating model. Identify, assess, and escalate risks that could impact submission timelines or regulatory outcomes. Coordinate and prioritize regulatory submissions across portfolios and support submission planning activities. Oversee the preparation, publishing, and submission of high-quality regulatory packages, including eCTD, NEES, and paper submissions for investigational, marketing authorization, lifecycle management, and post-approval applications. Support submissions for a range of regulatory applications, including NDA, BLA, IND, CTA, PSUR, and Variations. Partner with Regulatory Project Managers and cross-functional teams to support submission strategy, planning, and execution. Provide submission planning support, including Excel-based roadmaps, storyboards, and briefing book timelines when a dedicated Submission Project Manager is not assigned. Ensure regulatory submissions meet technical format requirements, global standards, quality expectations, and applicable timelines. Monitor evolving regulatory publishing requirements and contribute to continuous improvement of global submission processes and standards. What You’ll Bring Bachelor’s degree or higher in Life Sciences, Pharmacy, or a related field. 5+…