Professions are characterized by several factors, including an identifiable body of knowledge, a pathway for advancing
knowledge and skills related to the profession and an emphasis on continued learning and development. This paper
presents the Regulatory ffairs Professionals Society (RAPS) Professional Development Framework (PD Framework) for
the healthcare product regulatory affairs (RA) profession. The PD Framework offers a model for describing the basic
body of knowledge and relevant skills of the RA profession across product lines, geographic locations and employer
types at four major career stages. The framework is the result of years of research and development carried out by
RAPS with the involvement of members worldwide. The studies’ results provide valuable insights into the nature of
the profession. The framework defines the profession by professional/career levels, domains that reflect steps in the
healthcare product lifecycle, the responsibilities and tasks of the RA professional at each step and the associated
core knowledge and skills required of the professional.
Regulatory Affairs Professional Development Framework: An Overview © 2007 Regulatory Affairs Professionals Society
