Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc
Job Summary
Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
Provides counsel to and manages a regulatory sub-function, ensuring timely preparation of scientifically valid applications and translating regulatory requirements into practical plans.
CSL Behring is a global biotherapeutics leader driven by the promise to save lives, focused on serving patients' needs by using the latest technologies.
Matching Summary
Acts as a leader with government regulator interactions and provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
Skills & Requirements
Must-have
government regulator interactions
pre-clinical submissions
clinical trials applications
marketing applications
biological regulations knowledge
regulatory sub-function management
Nice-to-have
collaboration across sites
stakeholder relationship management
inclusion and belonging culture
Key Requirements
12+ years' pharmaceutical industry experience
8+ years' Global Regulatory Affairs experience
10+ years' leadership experience
Advanced degree in Life Science or Business
Post graduate qualification (PhD, MD, MBA or other)