Level I
These individuals are new or relatively new to the profession with limited or no regulatory knowledge. Many have education and/or experience in science, clinical studies or engineering and understand specific aspects of the healthcare product arena. Throughout Level I, these individuals develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures and begin to develop the critical thinking skills essential to the profession.
Level I professionals should possess skills such as project management, writing, coordination, and interpersonal and communication skills. A science background and basic statistical knowledge are advantages. At this level, individuals coordinate and support technical and scientific regulatory activities, research regulations and guidance and maintain and organize key information sources. (Example job titles: coordinator and some associate positions.)
Level II
Level II professionals develop and expand upon an integrated understanding of the scope of practice of the regulatory profession throughout the product lifecycle. There is a strong emphasis on combining scientific and technical aspects of the profession, strong project management and critical thinking. Level II professionals often expand their involvement in international/multinational regulatory issues and begin more active involvement with concepts of regulatory strategy. At Level II, individuals demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and options; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission; registration; obtaining approval; documentation; compliance; postmarketing surveillance/vigilance; and distribution. Regulatory Affairs Certification (RAC) is targeted to professionals at this level. (Example job titles: some associate positions, specialist, and some assistant/associate manager positions.)
Level III
Level III professionals integrate regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. This level represents the move from the more technical and tactical dimensions of the regulatory professional scope of practice into more integrated lifecycle management, and a more strategic role. Individuals at this level have strong technical and management skills and are actively engaged in regulatory strategy and operations. They are often engaged in activities spanning the product lifecycle and are involved in business activities, management and strategy. Level III professionals demonstrate skills and knowledge in areas such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment as well as global communication; staff and vendor development and management; and influencing the regulatory environment. (Example job titles: manager, associate director, director.)
Level IV
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 diverse external 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 organizations 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.)