We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products
Job Summary
We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives and focused on serving patients’ needs by using the latest technologies.
At CSL, Inclusion and Belonging is at the core of our mission and who we are, fueling innovation and fostering a diverse workforce.
Matching Summary
We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products.
Skills & Requirements
Must-have
Global regulatory submission management
eCTD and NEES publishing formats
Health authority requirements knowledge
Vendor management for publishing
Electronic document management systems
Regulatory timelines and risk management
Nice-to-have
Cross-functional team collaboration
Strong organisational skills
Attention to detail
Matrixed global environment navigation
Strategic alignment of submissions
Key Requirements
Bachelor’s degree in Life Sciences or Pharmacy
5+ years pharmaceutical regulatory experience
Experience preparing dossiers for international markets
Knowledge of EU, US, Canada, Switzerland, Australia regulations