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; ensures timely preparation of organized and scientifically valid applications; provides expertise in translating regulatory requirements into practical, workable plans.
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
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
Develop regulatory strategies
Ensure regulatory compliance
Manage regulatory teams
Knowledge of biological regulations
Nice-to-have
Collaborative relationships across sites
Stakeholder relationship management
Culture of curiosity and empathy
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)