Regulatory Affairs Specialist

Regulatory Affairs Specialist. We have a position open for a hand’s on animal health Regulatory Affairs Specialist who can get things done. This is an opportunity to help shape and grow an emerging animal health company. The incumbent in this position will manage, prepare and submit documents and dossiers to the FDA, CVM and will lead and help prepare documents (applications, reports, protocols, responses, etc.) in appropriate format. The incumbent will submit documents and dossiers in a timely manner and will monitor the progress through the FDA, CVM. This role requires the incumbent to manage several projects at the same time and maintain relationships with the FDA CVM reviewers and other regulatory constituents. There is a 10% travel requirement to Rockville, MD mostly.

Qualifications include a scientific education (BS, MS, Engineering, DVM), good oral and written communication skills, the ability to work independently and as a team member, 3-5 years of experience in a similar position that includes interacting with the FDA’s Center for Veterinary Medicine (CVM). Qualified candidates must be authorized to work in the United States.

To be considered for this Regulatory Affairs Specialist Animal Health job opportunity, please apply here: