CSL Behring is hiring a Regulatory Submission Manager to oversee the preparation and submission of global regulatory packages for investigational and marketed products. The ideal candidate will have extensive experience in pharmaceutical regulatory affairs, particularly in submission management, and a strong understanding of health authority requirements
Job Summary
Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
Coordinate regulatory submission activities across multiple regions, partnering closely with cross-functional teams and external vendors.
Ensure compliance with global regulatory publishing and submission standards, while monitoring evolving international requirements.
Matching Summary
Match Score: 85
CSL Behring is hiring a Regulatory Submission Manager to oversee the preparation and submission of global regulatory packages for investigational and marketed products. The ideal candidate will have extensive experience in pharmaceutical regulatory affairs, particularly in submission management, and a strong understanding of health authority requirements.
Skills & Requirements
Must-have
global regulatory submissions
eCTD, NEES, and paper formats
health authority requirements
electronic document management systems
publishing vendor 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 EU, US, Canada, Switzerland, Australia