The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

  • pharmaceuticals
  • medical devices
  • in vitro diagnostics
  • biologics and biotechnology
  • nutritional products
  • cosmetics
  • veterinary products

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising, and postmarket surveillance.

Core Competencies

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels. The Framework breaks down the profession’s basic competencies into clear, easy-to-understand statements and provides a foundation for regulatory professionals, regulators and employers to design training, develop curriculum, and manage professional and career development.

Contact RAPS to receive a copy of the Regulatory Competency Framework

“The whole thing is just enormously valuable. I think there are three groups of people who benefit from it--first of all the professional. It lays out an expectation of what they need to master at each level of their careers and provides transparency. It’s enormously helpful for department heads. It sort of normalizes the profession, laying out what the competencies are at each level, keeping in mind that the skillsets might be different based on the work in specific areas like pharma, biologics or whatever. The same benefits are true for the employer and recruiters, offering a yardstick or benchmark against which expectations are set.”
Sue James, vice president, worldwide regulatory affairs, R&D compliance and quality, GlaxoSmithKline

The Framework is based on two primary dimensions: levels and domains. Levels refer to four distinct professional levels, while domains reflect broad categories of professional responsibilities. For each level and domain, the Framework presents statements that describe what a regulatory professional is expected to do. These statements can be used as a foundation for developing organization specific competency models.

Contact RAPS to receive a copy of the Regulatory Competency Framework