Volunteer Opportunity Details

The Job Task Analysis (JTA) is the process of identifying what a practitioner needs to know and do to be successful in a given field. The results of a JTA will serve as the foundation to update the Regulatory Affairs Certification (RAC) program, ensuring that it is fair, accurate, and reflective of current industry practices.

Volunteers are needed to play a critical role in the JTA process by providing their expertise and insights as it pertains to practicing regulatory affairs. Volunteers will meet in person for two days at the RAPS office in Rockville, MD, and virtually 2-3 times, with efforts made to accommodate the best times for everyone.

Here are some specific tasks that the volunteers will perform during the JTA:

• Identify key related job roles and responsibilities
• Define the core knowledge areas and critical work functions for with each job
• Develop task statements that describe the tasks that regulatory affairs professionals typically perform
• Rate the importance and frequency of each task
• Review and refine the task statements
• Identify the knowledge and skills that are required to successfully perform each task
• Provide input on certification content and requirements
• Review and update certification prerequisites and re-certification criteria
• Analyze survey results and provide feedback

Why volunteer for the RAC JTA Task Force?

The RAC JTA Task Force is a unique opportunity to:

• Make a significant contribution to the RAC certification program
• Make a significant contribution to the regulatory profession
• Gain valuable experience in the JTA process and exam development
• Network with other experienced regulatory affairs professionals
• Gain useful insights about the scope of regulatory practice
• Enhance your professional reputation and expertise

Requirements:

• Must be a current RAC certification holder
• Must have a minimum of 3 years of regulatory experience related to pharmaceuticals or medical devices
• Must hold a regulatory position or be a first-line supervisor in one of the following areas:
  • Regulatory affairs
  • Clinical research
  • Quality assurance
• Must be able to meet in person at the RAPS office (Rockville, MD) for 2 full consecutive days between 25-26 February 2025. Travel expenses will be reimbursed.
• Available for 2-3 virtual meetings, with efforts made to accommodate the best times for everyone.