Regulatory Affairs Associate Manager - Generalist

There is an Immediate opening for a Regulatory Affairs Associate Manager Generalist out of the Princeton NJ area. This role will have a strong strategy focus as well as heavy submission and FDA interaction. This position requires someone that is familiar with the contents of the regulatory documents, and as well as familiarity with the entire drug lifecycle from pre-clinical to post-clinical. The right candidate will have broad experience with FDA regulations and requirements and be familiar with all aspects of regulatory.

-Minimum of BS degree in life sciences or related field
-Minimum 5 years in pharmaceutical regulatory affairs, with an emphasis on submission strategy
-Review outgoing FDA correspondence (INDs, amendments, supplements) for completeness, correctness and compliance to FDA regulations and guidelines.
-Direct FDA Contact
-Demonstrates a thorough understanding of FDA guidelines
-Demonstrates strong understanding of R&D processes required for NDA andINDsubmissions.
-Ability to negotiate response to FDA deficiencies
-Excellent oral and written communication skills

To find out more about Real Staffing please visit www.realstaffing.com