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. The Regulatory Affairs Professionals Society (RAPS) developed the Professional Development Framework (PD Framework) for the healthcare product regulatory profession. The PD Framework offers a model for describing the basic body of knowledge and relevant skills for the regulatory profession across product lines, geographic locations and employer types at four major career stages. The PD Framework is based on two primary dimensions:
Level - referring to one of four professional/career levels
Domains - reflect scope of responsibilities throughout the product lifecycle
The levels and domains are organized within the framework by premarket and postmarket stages of product development, strategic planning and interfacing activities. For each level and domain, the PD Framework presents:
- Basic Professional Knowledge
- Institutional Knowledge
- Skills/Abilities
- Tasks/Responsibilities
Level IV Framework
If you have more than 10 years of regulatory experience, you are a Level IV professional. Level IV professionals are strategic and innovative. They assume a strategic lead role representing the regulatory perspective while proactively developing new and often innovative approaches for pursuing business objectives within the regulatory framework. Some of the most important facets of the Level IV professional’s scope of practice are responsibilities and tasks related to strategic planning and interfacing throughout the product lifecycle, both within the organization and with a diverse external range of groups.
Based upon a strong and extensive understanding of the role of the profession in the product lifecycle and the dynamics of regulatory processes, these professionals are also engaged in policy development within their organizations and with external groups. They typically are leaders and mentors within their organization and for the profession. At Level IV, professionals must be able to work effectively in multinational/multicultural environments. (Example job titles: may include directors in some organizations, vice president, executive director, chief regulatory officer)
The PD Framework is an important tool in planning your professional development.