about 1 year ago
The Senior Director of Global Regulatory will implement regulatory strategies to support achievement of clinical program goals.
Lead Health Authority meetings associated with the program. Responsible for the program’s global regulatory plan and its execution.
Identify and assess regulatory risks associated with clinical development activities.
Development and oversight of submissions - INDs and CTAs globally.
Have significant influence on achievement of corporate and program objectives and key results.
Ensure that plans meet global regulatory requirements.
Must have significant experience w/US FDA regulations and knowledge of the drug development process.
15+ years of industry experience.