The primary responsibility of the Regulatory Affairs Manager is assuring the management, retention, and control of all applicable IND/IDE submissions made to the U.S.Food and Drug Administration (FDA);supervision and training of Regulatory Specialists; independent execution of regulatory-related decisions/strategies; and coordinate work with the ORRA Study Monitors to assure that FDA deadlines are met. The manager must have advanced ability to coordinate multiple projects through effective oral and written communication. Extensive knowledge of FDA law and regulations in particular 21 CFR11, 50, 54, 56, 312, and 812 are required.
All UAMS employees will treat others with Dignity and Respect. We communicate and share complete and unbiased information, assuring our colleagues receive timely, complete, and accurate information in order make informed decisions.
We participate in institutional initiatives and encourage the participation of others. We collaborate in policy and program development, implementation, and evaluation using best practices in delivering quality service.
The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving the health, health care, and well-being of Arkansans.
UAMS offers amazing benefits and perks:
Salary: offered commensurate with experience
Knowledge, Skills, & Abilities: