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CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have over five years of experience in pharmaceutical regulatory affairs, particularly in submission management, and will thrive in a collaborative environment focused on innovation and patient care.
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Job Summary
Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
Coordinate submission priorities and planning across business units and product portfolios, while overseeing publishing vendors.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients' needs by using the latest technologies.
Matching Summary
Match Score: 75
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CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have over five years of experience in pharmaceutical regulatory affairs, particularly in submission management, and will thrive in a collaborative environment focused on innovation and patient care.
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Skills & Requirements
Must-have
global regulatory submissions
submission preparation activities
eCTD, NEES, and paper formats
electronic document management systems
publishing vendors oversight
Nice-to-have
advancing regulatory excellence
meaningful work
global collaboration
culture of curiosity and empathy
Key Requirements
Bachelor’s degree or higher
5+ years pharmaceutical regulatory experience
Experience preparing dossiers for core and international markets
Working knowledge of health authority requirements