Description
Is new drug development your passion? Do you enjoy seeing a project through from start to finish? Do you understand how to utilize your strong social skills to create results?If this sounds like you- I would urge you to apply for this opportunity.
Requirements
-Experience interfacing directly with the FDA, global regulatory bodies
-Bachelor's degree and 7+ years of RA experience OR Master's degree and 5+ years of RA experience
-Strong project management skills
-High attention to detail
-Mentorship/Supervisory Experience
Responsibilities
-Develop departmental strategy and ensure regulatory compliance
-Maintain submission timelines
-Track and maintain full Regulatory applications including initial INDS and NDAs
-Develop regulatory briefing documents for pre-IND, end of phase II , and pre-NDA meetings with the FDA
Looking forward to speaking with you!