A regulatory affairs specialist assists in the implementation of international and domestic regulatory strategies. They help with the preparation, coordination, and compiling of applications to foreign and domestic regulatory agencies. Regulatory affairs specialist respond to common inquires from customers, members of the business community, and regulatory agencies. They are required to participate in customer complaint reviews to ensure global regulatory compliance and need to address all complaints and file all necessary paperwork.
These specialists may need to research certain problems and inform management when they troubleshoot and fix them. Regulatory affairs specialist is responsible for implementing training guidelines and training all member of the team on important regulations. They also need to generate ideas and implementation plans for organizations in regards to basic regulatory compliance.
Regulatory affairs specialists are required to have a bachelor's degree in scientific development or a related field. Having experience in FDA submissions is a plus, but not required. Regulatory affairs specialist must have excellent verbal and written skills, as they are required to write reports and present them to upper management. It is important for a regulatory affairs specialist to be up to date as information on new regulations and laws as they become available.
Regulatory Affairs Specialist Tasks
Ensure company compliance with all regulations and laws pertaining to company business.
Compile and maintain appropriate technical documents for regulatory submissions.
Conduct research to support regulatory submissions.
Prepare and submit documentation to regulatory agencies.