The Regulatory Submission Manager will play a key role in delivering high-quality and timely global regulatory submissions supporting investigational and marketed products
Job Summary
The Regulatory Submission Manager will play a key role in delivering high-quality and timely global regulatory submissions supporting investigational and marketed products.
The company CSL Behring is a global biotherapeutics leader focused on innovative therapies in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
CSL fosters a culture of inclusion and belonging, emphasizing diversity, empathy, and innovation to better serve patients and stakeholders worldwide.
Matching Summary
The Regulatory Submission Manager will play a key role in delivering high-quality and timely global regulatory submissions supporting investigational and marketed products.
Skills & Requirements
Must-have
Global regulatory submission management
eCTD and NEES publishing
Cross-functional team coordination
Regulatory dossier preparation
Vendor management and oversight
Knowledge of ICH guidelines
Nice-to-have
Strong organisational skills
Attention to detail
Experience in matrixed global environment
Global collaboration mindset
Key Requirements
Bachelor’s degree in Life Sciences or Pharmacy
5+ years pharmaceutical regulatory experience
Experience with international health authority requirements