Regulatory Affairs Professional
| People
who work in
Regulatory Affairs
are responsible for developing and
monitoring procedures to ensure that a product is manufactured in
accordance with appropriate laws and requirements.
Regulatory Affairs Professionals are key players in new drug development. A Regulatory Affairs technician compiles and analyzes data, prepares reports, and makes recommendations for changes and/or improvements, and may also investigate problems and determine solutions. He or she also maintains appropriate validation documentation and files. |
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| Although the work emphasizes regulatory knowledge, scientific training is also valued and helpful. To do the job well requires one to be a generalist, comfortable working across a range of scientific disciplines, and competent in asking questions and finding answers. | |
