Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management
Job Summary
Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines.
At Praxis, we believe that taking care of our people (and *their* people) is important, so we provide a world class benefits package to help you thrive.
Matching Summary
Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management.
Salary
$160,000—$180,000 USD; Discretionary quarterly bonus, long-term stock incentives and ESPP; 99% premium paid for medical, dental and vision plans, life insurance, AD&D, disability benefits, wellness benefit, PTO, paid holidays
Skills & Requirements
Must-have
Global regulatory strategies
Clinical development programs
IND lifecycle management
Health authority interactions
Regulatory submissions preparation
Nice-to-have
Solution-oriented mindset
Work with urgency and innovation
Collaborative team environment
Translating regulatory requirements
Key Requirements
Six to ten years of experience
Advanced degree in life science
Experience managing IND lifecycle
Experience supporting health authority interactions
Experience in rare disease/neurological indications