Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products
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, providing oversight of 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
Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
Skills & Requirements
Must-have
global regulatory submissions
eCTD, NEES, and paper formats
electronic document management systems
health authority requirements
ICH guidelines
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 health authority requirements
Familiarity with Veeva RIM Suite
Experience partnering with or managing outsourced publishing vendors