Not specified (assumed hybrid based on industry standards).
Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team collaboration
CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have extensive experience in regulatory affairs, particularly in publishing and submission management, and will thrive in a collaborative, detail-oriented environment
Job Summary
Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
Oversee the preparation, publishing, and submission of global regulatory packages across various application types.
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: 85
CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have extensive experience in regulatory affairs, particularly in publishing and submission management, and will thrive in a collaborative, detail-oriented environment.
Skills & Requirements
Must-have
Global regulatory submissions
eCTD, NEES, and paper formats
Cross-functional team collaboration
Vendor oversight and performance monitoring
ICH guidelines compliance
Nice-to-have
Advancing regulatory excellence
Meaningful work and global collaboration
Inclusion and Belonging culture
Key Requirements
Bachelor’s degree (or higher) in Life Sciences, Pharmacy, or related discipline
5+ years pharmaceutical regulatory experience
Experience preparing dossiers for core and international markets
Working knowledge of health authority requirements (EU, US, Canada, Switzerland, Australia)
Familiarity with Veeva RIM Suite
Experience partnering with or managing outsourced publishing vendors