What is Regulatory Affairs?
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
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 within Regulatory Affairs
Regulatory professionals come from diverse backgrounds. Most regulatory professionals have earned a bachelor's degree, and more than half have an advanced degree, most often in a scientific or technical field. In addition, regulatory professionals usually have experience in other careers before transitioning into regulatory affairs.
Although there are some university degree and graduate certificate programs in regulatory affairs and related areas, experience is a key asset for regulatory professionals. Valuable skills include project management and organization, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organization.
Continuing education and professional development are critical to the regulatory professional. Regulatory professionals must keep up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.
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