Regulatory Affairs Specialists

Is innovation your inspiration?
A rapidly growing, fully integrated pharmaceutical company, Upsher-Smith is bringing its innovative spirit to New Jersey. We pursue drug therapies to improve people’s lives, with a portfolio focused on women’s health, dermatology, cardiology and, most recently, epilepsy and Parkinson’s disease. Now, we’re expanding with a new satellite office in Morristown, New Jersey. If you are driven to be the best and seek a challenging career opportunity, we invite you to bring your passion and talents to our highly valued team.
 
Regulatory Affairs Professionals
As an important part of our NCE program, our Regulatory Affairs Specialists will provide strategic and tactical support for our initiatives. In addition, the individuals we select will serve as primary contact with FDA and international regulatory authorities for designated programs and may participate in due diligence activities for licensing opportunities.
  
RA Specialists must have a BS in chemistry, biology or related field; an advanced degree is highly desired. We require 6-8 years of regulatory experience within the pharmaceutical industry, including previous NDA/IND experience with an emphasis on regulatory roles and responsibilities for initial IND, pre-clinical studies and Phase 1, 2 and 3 clinical trials. Experience with the regulatory aspects of pharmacovigilance is essential. Candidates with the training or experience to liaise effectively with Clinical and Medical Affairs colleagues are preferred.
 
We offer opportunities for professional development and a full roster of excellent benefits.