Professional Development in Regulatory Affairs

This article explores the many ways in which regulatory affairs (RA) professionals achieve growth and developmental in their careers. It also explores ways to encourage non-regulatory professionals interested in RA to develop their skills to fit into the RA profession. The article also attempts to explain the day-by-day functions, responsibilities and decisions of regulatory professionals and their effect on compliance issues in drug/biologic/device product development,approval and marketing.In order to establish and maintain a focused career in regulatory affairs, there is a continuous need to develop through training, learning and participating in the regulatory developmental process, in addition to interacting with others in the profession. One should always seek all available opportunities to expand one’s RA knowledge by attending internal company scientific presentations and external research and development seminars, participating in regulatory compliance workshops and taking regulatory training classes as often as possible. To achieve competency in RA, one should be prepared to answer the following questions:
• What skill sets are needed to perform the various regulatory functions?
• When does one go about implementing a plan to learn such skills?
• Where does one obtain such skills?
• How does one establish, maintain and improve these skill sets?
• What are the desired skills?
Having been exposed to different departments at various companies, RA departments should always strive to attract talented individuals with a good fit to the company and then provide a high level of experience that will increase their know-how. Regulatory departments should work diligently to retain their associates and provide incentives to prevent trained, experienced and talented individuals from leaving. Relevant experience, a good fit with the position and an effective department, as well as a company culture that is committed to excel, are all necessary ingredients in the success of an RA professional and the industry as a whole.

SOURCE:Regulatory Affairs Professional Society