Acts as a leader with government regulator interactions and provides development and implementation strategies for submissions and applications
Job Summary
Acts as a leader with government regulator interactions and provides development and implementation strategies for submissions and applications.
Provides counsel to and manages a regulatory sub-function, ensuring timely preparation of scientifically valid applications and translating regulatory requirements into practical plans.
Maintains a strong collaborative relationship across CSL sites, including site communications and knowledge sharing, while developing and maintaining good working relationships with all stakeholders.
Matching Summary
Acts as a leader with government regulator interactions and provides development and implementation strategies for submissions and applications.
Skills & Requirements
Must-have
government regulator interactions
develop regulatory strategies
manage regulatory sub-function
ensure regulatory compliance
maintain biological regulations knowledge
Nice-to-have
collaborative relationships across sites
knowledge sharing
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)