Regulatory Affairs Associate


Coté Orphan (CO) is a small but rapidly expanding regulatory affairs consulting firm located in Silver Spring, MD that focuses exclusively on the development of new therapies for patients with rare diseases. Since establishment in May 2012, CO has attracted regulatory affairs and clinical trials work from the largest to the smallest innovators in orphan drugs with clients seeking assistance with a wide variety of regulatory actions including US and EMA ODDs, BTDs, pre-IND briefing packages and meeting strategy/conduct, clinical trial design, NDA and BLA submissions, and broad regulatory strategy reviews. The extraordinary growth of CO has been fueled in large part by the expansive network of its principal, Timothy Coté, MD MPH who served as Director of FDA’s Office of Orphan Products Development from 2007-2011.

Coté Orphan seeks a regulatory affairs associate with experience in IND submission and management, NDA submissions, 505b2 submissions, orphan designation applications and FDA meetings management.  A strong, client-focused work ethic is mandatory, as is the ability to work independently on mission-critical projects.  Writing and oral communication skills are essential.  RAC preferred, previous FDA experience preferred, 7+ years regulatory experience preferred, but none are mandatory. 

Salary negotiable DOE.  Full health care and retirement benefits, flexible hours and the excitement of a small, youthful team focused on new opportunities to create drugs for people who desperately need them. 

Interested applicants should send letters of interest and CVs to Erin Lawless-Miller