Regulatassociate Principal

Our client has experienced growth in their pipeline, and is looking to bring aboard a new Regulatory Affairs Associate Principal. This is an extremely exciting opportunity in Pennsylvania offering a competitive salary as well as generous benefits. The position has strong international focus, and the right candidate will lead regulatory projects in a diverse range of therapeutic areas.

Job Responsibilities & Qualifications:

-Liaise with cross functional teams
-Lead regulatory projects at various stages
-Attend FDA meetings
-Knowledge of BLA, IND, NDA, 510k and PMA submissions, Combination and Transgenic Products
-Well versed with US FDA regulations for Labeling and Advertising and Promotion
-Prior experience in international regulatory submissions
-Well versed with US FDA regulations for Labeling and Advertising and Promotion
-Minimum of 7 years of Regulatory experience
-Extensive experience with NDAs, INDs, and sNDAs
-Knowledge of diverse therapeutic areas
-Ability to multitask

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