Imagine if every time you took a new medicine or ate a new food product,
you were taking a chance on your health. The Food and Drug Administration
(FDA) tries to make sure that doesn't happen. It has regulations to ensure
Someone has to make sure these standards are met. Enter the regulatory
Regulatory affairs workers help develop new drugs and other products. Then
they prepare documents on the products. They give these documents to the regulatory
agency. That's usually the FDA.
"There is a responsibility to both the public and the company to provide
complete and accurate information," says Paola Battiston, a science professor.
Larry Gundersen heads the regulatory affairs programs at San Diego State
University. "The challenge is to assist the company in adhering to these laws
and regulations," he says. This must be done in a cost-effective way.
These workers must understand how the different agencies work. This means
keeping up with regulations that are always changing.
Gundersen says they "must also have a reasonable working knowledge of many
aspects of the development process."
That means they must know about chemistry, pharmacology and toxicology.
It's also important to understand manufacturing, quality control and advertising.
A regulatory affairs associate may work for the government, a pharmaceutical
company or a consulting firm.
Martha Feldman works with a drug development company in Washington. She
says this is usually a five-day, 40-hour workweek kind of job.
"Workweeks vary based upon where the company is on a submission," she adds.
"As a deadline approaches, there may be 60- to 80-hour weeks."
There are no major physical requirements for this job, since you are most
likely to work in an office or laboratory setting. It may, however, involve
going around on inspections.