Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various applications
Job Summary
Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various 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, fostering site communications, knowledge sharing, and good working relationships with all stakeholders.
Matching Summary
Acts as a leader with government regulator interactions and provides development and implementation strategies for timely submission and approval of various applications.
Skills & Requirements
Must-have
government regulator interactions
regulatory sub-function management
biological regulations knowledge
stakeholder relationship management
Nice-to-have
scientific innovation
patient-focused culture
collaboration and knowledge sharing
Key Requirements
12+ years pharmaceutical industry experience
8+ years Global Regulatory Affairs experience
10+ years leadership experience
Advanced degree in Life Science or Business with post-graduate qualification